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Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose Effects of Lubricating Agents with Different Osmolalities on Tear Osmolarity and Other Tear Function Tests in Patients with Dry Eye Comparison of the clinical effects of carbomer-based lipid-containing gel and hydroxypropyl-guar gel artificial tear formulations in patients with dry eye syndrome: a 4-week, prospective, open-label, randomized, parallel-group, noninferiority study. A randomized crossover study comparing trehalose/hyaluronate eyedrops and standard treatment: patient satisfaction in the treatment of dry eye syndrome SmartPlug Versus Silicone Punctal Plug Therapy for Dry Eye: A Prospective Randomized Trial Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease Autologous serum eye drops for dry eye after LASIK. Effects of Systane® Balance on noninvasive tear film break-up time in patients with lipid-deficient dry eye Clinical evaluation of an HP-guar gellable lubricant eye drop for the relief of dryness of the eye Randomized Double-Blind Clinical Trial of Autologous Serum Versus Artificial Tears in Dry Eye Syndrome Effectiveness of rituximab treatment in primary Sjögren's syndrome: a randomized, double-blind, placebo-controlled trial. Pilot, Prospective, Randomized, Double-masked, Placebo-controlled Clinical Trial of an Omega-3 Supplement for Dry Eye Effectiveness of Dry Eye Therapy Under Conditions of Environmental Stress A Randomized Double-Masked Study of 0.05% Cyclosporine Ophthalmic Emulsion in the Treatment of Meibomian Gland Dysfunction Pilocarpine Hydrochloride for the Treatment of Xerostomia in Patients with Sjögren's Syndrome in Taiwan—A Double-blind, Placebo-controlled Trial Oral sea buckthorn oil attenuates tear film osmolarity and symptoms in individuals with dry eye. [Oral flaxseed oil (Linum usitatissimum) in the treatment for dry-eye Sjögren's syndrome patients]. Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. Systemic omega-6 essential fatty acid treatment and pge1 tear content in Sjögren's syndrome patients. A randomised, double-masked comparison study of diquafosol versus sodium hyaluronate ophthalmic solutions in dry eye patients Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial Lacrimal Punctum Occlusion in the Treatment of Severe Keratoconjunctivitis Sicca Caused by Sjögren Syndrome: A Uniocular Evaluation An Investigation of the Efficacy of a Novel Ocular Lubricant A comparison of cyclosporine 0.05% ophthalmic emulsion versus vehicle in Chinese patients with moderate to severe dry eye disease: an eight-week, multicenter, randomized, double-blind, parallel-group trial. Efficacy of Cyclosporine 0.05% Ophthalmic Emulsion in Contact Lens Wearers With Dry Eyes [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Reduction of fatigue in Sjögren syndrome with rituximab: results of a randomised, double-blind, placebo-controlled pilot study Effects of dietary supplementation with fish oil on dry eye syndrome subjects: randomized controlled trial. Corneal staining reductions observed after treatment with Systane® Lubricant Eye Drops Comparison of Topical Cyclosporine, Punctal Occlusion, and a Combination for the Treatment of Dry Eye Tofacitinib (CP-690,550), a Janus kinase inhibitor for dry eye disease: results from a phase 1/2 trial. Silicone versus collagen plugs for treating dry eye: results of a prospective randomized trial including lacrimal scintigraphy. A comparative clinical trial of the efficacy of two different aqueous solutions of cyclosporine for the treatment of moderate-to-severe dry eye syndrome The Effect of Decreasing the Dosage of Cyclosporine A 0.05% on Dry Eye Disease After 1 Year of Twice-Daily Therapy Efficacy and safety of diquafosol ophthalmic solution in patients with dry eye syndrome: a Japanese phase 2 clinical trial. A randomized, double-masked, placebo-controlled, multicenter comparison of loteprednol etabonate ophthalmic suspension, 0.5%, and placebo for treatment of keratoconjunctivitis sicca in patients with delayed tear clearance. Etanercept in the treatment of patients with primary Sjögren's syndrome: a pilot study. Safety and efficacy of cyclosporine 0.05% drops versus unpreserved artificial tears in dry‐eye patients having laser in situ keratomileusis Double-Masked, Placebo-Controlled Safety and Efficacy Trial of Diquafosol Tetrasodium (INS365) Ophthalmic Solution for the Treatment of Dry Eye Comparison of autologous serum and umbilical cord serum eye drops for dry eye syndrome. Setting Priorities for Comparative Effectiveness Research on Management of Primary Angle Closure: A Survey of Asia-Pacific Clinicians Therapeutic effect of cevimeline on dry eye in patients with Sjögren's syndrome: a randomized, double-blind clinical study. Carbomer and Sodium Hyaluronate Eyedrops for Moderate Dry Eye Treatment Effect of dehydroepiandrosterone administration on fatigue, well-being, and functioning in women with primary Sjögren syndrome: a randomised controlled trial The efficacy of cevimeline hydrochloride in the treatment of xerostomia in Sjögren’s syndrome in southern Chinese patients: a randomised double-blind, placebo-controlled crossover study Topical cyclosporine A for the dry eye findings of thyroid orbitopathy patients A randomized controlled trial of omega-3 fatty acids in dry eye syndrome. Effect of a liposomal spray on the pre-ocular tear film. Effects of the topical treatment with NSAIDs on corneal sensitivity and ocular surface of Sjögren's syndrome patients Efficacy of Commercially Available Topical Cyclosporine A 0.05% in the Treatment of Meibomian Gland Dysfunction Clinical evaluation of the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome: a prospective, randomized, multicenter study Lamivudine is not effective in primary Sjögren's syndrome. [Comparative investigation of treatments for evaporative dry eye]. Effect of an Oil-in-Water Emulsion on the Tear Physiology of Patients With Mild to Moderate Dry Eye Oral omega-6 essential fatty acid treatment in contact lens associated dry eye. Additive Effect of Preservative-free Sodium Hyaluronate 0.1% in Treatment of Dry Eye Syndrome With Diquafosol 3% Eye Drops Efficacy and safety of 0.18% sodium hyaluronate in patients with moderate dry eye syndrome and superficial keratitis Tear osmolarity measurement using the TearLab Osmolarity System in the assessment of dry eye treatment effectiveness. A comparison of vitamin a and cyclosporine a 0.05% eye drops for treatment of dry eye syndrome. Low serum levels of sex steroids are associated with disease characteristics in primary Sjogren's syndrome; supplementation with dehydroepiandrosterone restores the concentrations. [Improvement of dry eye symptoms with polyunsaturated fatty acids]. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Effects of Topical Cyclosporine A Plus Artificial Tears Versus Artificial Tears Treatment on Conjunctival Goblet Cell Density in Dysfunctional Tear Syndrome An Evaluation of the Efficacy of a Cyclosporine-Based Dry Eye Therapy When Used With Marketed Artificial Tears as Supportive Therapy in Dry Eye Reversibility of dry eye deceleration after topical cyclosporine 0.05% withdrawal. Inefficacy of infliximab in primary Sjögren's syndrome: results of the randomized, controlled Trial of Remicade in Primary Sjögren's Syndrome (TRIPSS). Epithelial Healing and Visual Outcomes of Patients Using Omega-3 Oral Nutritional Supplements Before and After Photorefractive Keratectomy: A Pilot Study Efficacy of 0.18% hypotonic sodium hyaluronate ophthalmic solution in the treatment of signs and symptoms of dry eye disease. Short-term consumption of oral omega-3 and dry eye syndrome. Effects of Diquafosol Sodium Eye Drops on Tear Film Stability in Short BUT Type of Dry Eye Efficacy of Sodium Hyaluronate and Carboxymethylcellulose in Treating Mild to Moderate Dry Eye Disease Randomized, phase III study comparing osmoprotective carboxymethylcellulose with sodium hyaluronate in dry eye disease The Effect of an Artificial Tear Combining Hyaluronic Acid and Tamarind Seeds Polysaccharide in Patients with Moderate Dry Eye Syndrome: A New Treatment for Dry Eye Acupuncture treatment in patients with keratoconjunctivitis sicca: a pilot study. Etanercept in Sjögren's syndrome: a twelve-week randomized, double-blind, placebo-controlled pilot clinical trial. Clinical Performance of a Mid-Viscosity Artificial Tear for Dry Eye Treatment [Effects of acupuncture on lactoferrin content in tears and tear secretion in patients suffering from dry eyes: a randomized controlled trial]. [Effect of integral syndrome differentiation acupuncture on the tear film stability in the patient of xerophthalmia]. A comparative assessment of the efficacy of carbomer gel and carboxymethyl cellulose containing artificial tears in dry eyes [Efficacy assessment of Nutrilarm®, a per os omega-3 and omega-6 polyunsaturated essential fatty acid dietary formulation versus placebo in patients with bilateral treated moderate dry eye syndrome]. Topical cyclosporine 0.05% for the prevention of dry eye disease progression.
PURPOSE The lipid tear film stabilizes the tears by lowering the surface tension and preventing aqueous tear evaporation and may be analyzed by kinetic analysis of the tear interference images . This study investigated changes in the lipid film after application of a new emulsion-based eye drop of Refresh Endura ( Allergan , Irvine , CA ) in normal subjects and patients with dry eyes . DESIGN Comparative , nonr and omized interventional study . PARTICIPANTS Five normal subjects and 10 aqueous tear deficiency ( ATD ) patients with or without lipid tear deficiency were enrolled prospect ively . METHODS A complete eye examination was performed , including symptom score , tear break-up time , dye staining , and fluorescein clearance test . One eye received a single dose of emulsion eye drop ( EED ) , whereas the other eye received nonpreserved saline as a control . Kinetic analysis of tear interference images taken by DR-1 ( Kowa , Japan ) was performed before and at various times after instillation of the drops . MAIN OUTCOME MEASURES Symptoms , pattern , thickness , and spread time of the tear film . RESULTS Compared with the control , all eyes receiving EED showed rapid restructuring of the preexisting lipid film . In normal persons , restructuring result ed in a thick lipid b and across the cornea and a significant increase of the lipid film thickness . For ATD patients , EED application result ed in either a scant , irregular tear film , which became covered by the lipid film , or a modified lipid film changed without forming a b and or irregularities .  Emulsion eye drops tended to be more comfortable in patients with more severe ATD . Kinetic analysis showed that the mean spread time improved for all patients after EED when compared with baseline or with controls ( P<0.05 ) . CONCLUSIONS Emulsion eye drop produces significant changes in the tear film of normal and dry eye patients . Further investigation with a prolonged period of treatment is warranted to establish whether EED may help improve the spread and thickness of the lipid tear film in moderate and severe dry eyes Background Dysfunction of the meibomian gl and ( MG ) is among the most frequent causes of ophthalmological symptoms . The inflammation seen in meibomian gl and dysfunction ( MGD ) is part of its pathogenesis , and evidence of the antioxidant-inflammatory properties of omega-3 fatty acids suggests this to be an appropriate treatment for MGD . Objective We aim ed to assess the effectiveness of omega-3 fatty acids versus placebo , in improving the symptoms and signs of MGD . Methods We conducted a r and omized and double-mask trial of 3 months duration . We enrolled 61 patients who presented with symptomatic MGD and no tear instability ( defined as tear breakup time [ TBUT ] < 10 seconds ) . Participants were r and omly assigned to two homogeneous subgroups . For patients in group A , the study treatment included cleaning the lid margins with neutral baby shampoo and use of artificial tears without preservatives , plus a placebo oral agent . For patients in group B , the study treatment included cleaning the lid margins with neutral baby shampoo and use of artificial tears without preservatives , plus oral supplementation with omega-3 fatty acids . We performed the following tests : ( 1 ) TBUT ; ( 2 ) Schirmer I test ; ( 3 ) Ocular Surface Disease Index © ( OSDI © ; Allergan , Inc. , Irvine , CA , USA ) ; ( 4 ) MG expression ; ( 5 ) evaluation of lid margin inflammation ; and ( 6 ) interpalpebral and corneal dye staining . Results After 3 months of evaluation , the mean OSDI , TBUT , lid margin inflammation , and MG expression presented improvement from the baseline values , in group B ( P < 0.01 , P < 0.001 , P < 0.0001 , P < 0.0001 , respectively ) . The Schirmer test results were also improved and statistically significant ( P < 0.01 ) . Conclusion Oral omega-3 fatty acids , 1.5 grams per day , may be beneficial in the treatment of MGD , mainly by improving tear stability Purpose To evaluate the effect of a new , prescription-only medical food supplement containing omega-3 and omega-6 essential fatty acids on  dry eye signs and symptoms  , with or without concomitant topical cyclosporine . Methods A total of 43 subjects were r and omized and followed for 6 months . Group 1 ( n = 23 ) was assigned to take two soft geltabs of the medical food supplement by mouth twice daily for 6 months . Group 2 ( n = 20 ) was directed to take the medical food supplement in the same manner , along with topical cyclosporine , instilled twice daily during the last 3 months of the study . Subjects were evaluated at baseline , month 1 , month 3 , and month 6 . Primary outcome measures included tear breakup time ( TBUT ) , conjunctival staining , corneal staining , and change in subjective symptoms . Results Both groups had a statistically significant improvement in TBUT between baseline and month 6 . In the food supplement only group , TBUT improved by 0.805 seconds from baseline to month 6 . In the supplement/cyclosporine group , TBUT improved by 1.007 seconds from baseline . There was no statistically significant difference in TBUT between the two groups at baseline , month 3 , or month 6 . There were no significant differences in corneal or conjunctival staining between or within groups . Subjective symptoms were also improved in both groups . Conclusion Supplementation with the proper balance of omega-3 and omega-6 essential fatty acids improved TBUT and relieved patient symptoms . The addition of topical cyclosporine did not convey any statistically significant improvement in TBUT beyond that achieved by the supplement Purpose To evaluate the effects of acupuncture compared to a control group using artificial tears . Methods Setting & design : multicenter r and omised controlled trial ( three local research hospitals of South Korea ) . Study Population : 150 patients with moderate to severe dry eye . Intervention : Participants were r and omly allocated into four weeks of acupuncture treatment ( bilateral BL2 , GB14 , TE 23 , Ex1 , ST1 , GB20 , LI4 , LI11 and single GV23 ) or to the artificial tears group ( sodium carboxymethylcellulose ) . Main Outcome Measure(s ) : The ocular surface disease index ( OSDI ) , tear film break-up time ( TFBUT ) , Schirmer Ι test , visual analogue scale ( VAS ) for self- assessment of ocular discomfort , general assessment ( by both acupuncture practitioners and participants ) and quality of life ( QOL ) through the Measure Yourself Medical Outcome Profile-2 ( MYMOP-2 ) . Results There was no statistically significant difference between two groups for the improvement of dry eye symptoms as measured by OSDI ( MD −16.11 , 95 % CI [ −20.91 , −11.32 ] with acupuncture and −15.37 , 95 % CI [ −19.57 , −11.16 ] with artificial tears ; P = 0.419 ) , VAS ( acupuncture : −23.84 [ −29.59 , −18.09 ] ; artificial tears : −22.2 [ −27.24 , −17.16 ] , P = 0.530 ) or quality of life ( acupuncture : −1.32 [ −1.65 , −0.99 ] ; artificial tears : −0.96 [ −1.32 , −0.6 ] , P = 0.42 ) immediately after treatment . However , compared with artificial tears group , the OSDI ( acupuncture : −16.15 [ −21.38 , −10.92 ] ; artificial tears : −10.76 [ −15.25 , −6.27 ] , P = 0.030 ) and VAS ( acupuncture : −23.88 [ −30.9 , −16.86 ] ; artificial tears : −14.71 [ −20.86 , −8.55 ] , P = 0.018 ) were significantly improved in the acupuncture group at 8 weeks after the end of acupuncture treatment . TFBUT measurements increased significantly in the acupuncture group after treatment . Conclusions Acupuncture may have benefits on the mid-term outcomes related to dry eye syndrome compared with artificial tears . Trial registration Clinical Trials.gov NCT01105221 PURPOSE The effective management of dry eye must include a clinical ly meaningful reduction in ocular staining . Evaluations of corneal and conjunctival staining and other ocular symptoms of dry eye were conducted for a new formulation of polyethylene glycol 400/propylene glycol-based lubricant eye drops containing hydroxypropyl guar as a gelling agent ( Test Product ) in comparison to Optive Lubricant Eye Drops ( Control Product ) in adult patients with dry eye . METHODS One hundred thirteen patients , 18 years of age and older , with dry eye were enrolled in a prospect i ve , double-masked , multisite , parallel-group study . After a 2-week run-in period during which patients administered aqueous saline eye drops 4 times daily ( QID ) in each eye , patients were r and omized ( 1:1 ) to receive either Test Product or Control Product to be administered QID for 6 weeks . Efficacy and safety were evaluated by corneal and conjunctival staining scores , tear film breakup time , assessment s of ocular symptoms , ocular surface disease index ( OSDI ) scores , dry eye treatment satisfaction , visual function-14 question naires , and adverse events . RESULTS The intent-to-treat data set included 105 patients r and omized to Test Product ( n = 52 ) or Control Product ( n = 53 ) . Patients primarily were between the ages of 18 - 64 years ( 70.5 % ) , female ( 73.3 % ) , white ( 93.3 % ) , and not Hispanic ( 81.9 % ) . Patients in the Test Product group exhibited significantly lower mean corneal staining scores than the Control Product group at day 14 ( P = 0.0009 ) and day 42 ( P = 0.0106 ) , and significantly lower mean conjunctival staining scores at day 28 ( P = 0.0475 ) and day 42 ( P = 0.0009 ) . Patients in both treatment groups reported significant reductions in the mean scores for the ocular symptoms of dryness , gritty/s and y feeling , and burning ( P < or= 0.0021 for all comparisons to baseline ) . Lastly , a significantly lower OSDI score than baseline was reported at day 42 by patients in both the Test Product ( P = 0.0013 ) and Control Product ( P < 0.0001 ) groups . CONCLUSIONS The results of this study indicate that the Test Product significantly reduced corneal and conjunctival staining , indicating a reduction in disease severity . Evaluations of ocular staining scores provide clinical ly meaningful evidence of dry eye severity and are an important indicator of dry eye disease progression Background The purpose of this study was to compare changes in corneal staining in patients with dry eye after 6 weeks of treatment with Systane ® Gel Drops or Refresh Liquigel ® lubricant eye drops . Methods Patients aged ≥18 years with a sodium fluorescein corneal staining sum score of ≥3 in either eye and best-corrected visual acuity of 0.6 logarithm of the minimum angle of resolution or better in each eye who were using a lubricant eye gel or ointment for dry eye were included in this r and omized , parallel-group , multicenter , double-blind trial . Patients were r and omized to four times daily Systane ® Gel Drops ( polyethylene glycol 400 0.4 % and propylene glycol 0.3 % ) or Refresh LiquiGel ® Drops ( carboxymethylcellulose sodium 1 % ) for 6 weeks . The primary efficacy outcome was mean change from baseline to week 6 in sodium fluorescein corneal staining . Supportive efficacy outcomes included conjunctival staining , tear film break-up time , Patient Global Assessment of Improvement , Impact of Dry Eye on Everyday Life ( IDEEL ) Treatment Satisfaction/Treatment Bother Question naire , Single Symptom Comfort Scale , and Ocular Symptoms Question naire . The safety analysis comprised recording of adverse events . Results In total , 147 patients ( Systane group , n=73 ; Refresh group , n=74 ; mean ± st and ard deviation age , 57±16 years ) were enrolled and included in the safety and efficacy analyses  . Corneal staining was significantly reduced from baseline to week 6 for Systane and Refresh ( −3.4±2.5 and −2.5±2.6 units , respectively ; P<0.0001 , t-test ) , with a significantly greater improvement with Systane versus Refresh ( P=0.0294 ) . Results for conjunctival staining , tear film break-up time , and patient-reported outcome question naires were not statistically different between groups . No safety issues were identified ; adverse events were reported by 19 % of patients with Systane and 30 % of patients with Refresh eye drops . Conclusion Systane Gel Drops were associated with significantly better corneal staining scores versus Refresh Liquigel eye drops in patients with dry eye . Supportive efficacy outcomes were not significantly different between groups . Both treatments were well tolerated Abstract Purpose : To evaluate the effects of different artificial tear eye drops on Ocular Surface Disease Index ( OSDI ) , tear osmolarity , Schirmer ’s I test , and tear break-up time ( TBUT ) in patients with dry eye disease . Material s and methods : This 12-week , single-institution , single-masked , r and omized , pilot study was conducted in Turkey between March and July 2012 in patients with dry eye . Patients were r and omly assigned to receive Systane ® for their right eye and Eyestil ® for their left eye or to receive Tears Naturale II ® for their right eye and Refresh Tears ® for their left eyes . Outcomes were assessed at baseline and weeks 2 , 4 and 12 after treatment initiation . Results : Twenty-two patients received Systane ( right eye ) and Eyestil ( left eye ) and 21 patients received Tears Naturale ( right eye ) and Refresh ( left eye ) . At each visit and for each outcome , each treatment group demonstrated a significant improvement from baseline ( p < 0.001 ) ; however , none of these outcomes were significantly different among treatment groups at any visit . At week 12 , the mean OSDI improvement was similar between the Systane/Eyestil group ( −26.4 ± 10.6 ) and the Tears Naturale/Refresh group ( −27.6 ± 14.8 ) . The mean tear osmolarity decrease ( mOsm/L ) at week 12 was −33.8 ± 8.3 for Eyestil , −30.3 ± 9.2 for Refresh , −28.4 ± 8.2 for Systane and −25.7 ± 13.1 for Tears Naturale . The mean Schirmer ’s test increase at week 12 ( mm/5 min ) was 6.7 ± 3.4 for Eyestil , 6.4 ± 2.9 for Systane , 4.7 ± 2.4 for Tears Naturale and 4.7 ± 2.8 for Refresh . The mean TBUT increase at week 12 ( s ) was 7.0 ± 3.4 for Systane , 6.1 ± 3.3 for Eyestil , 5.8 ± 2.3 for Tears Naturale , and 5.6 ± 2.8 for Refresh . Conclusion : All four artificial tear formulations were effective in relieving dry eye signs and symptoms . Although the greatest improvement in two of the objective tests was achieved by Eyestil , the drug with the lowest osmolality , differences among the four artificial tear eye drops were not statistically significant BACKGROUND Most marketed artificial tears are substitutes for the aqueous layers of the tear film ; therefore , frequent instillation of artificial tears is necessary . Newer gel- , cellulose- , and mineral oil-based formulations have been design ed to overcome the disadvantages of current aqueous tear substitutes by offering prolonged retention times . OBJECTIVES The aim of this study was to compare the efficacy , safety , and local tolerance of artificial tears containing carbomer-based lipids or hydroxypropyl (HP)-guar gel in patients with dry eye syndrome . METHODS A 4-week , prospect i ve , r and omized , parallel-group , comparative , noninferiority study was conducted at the Taipei Medical University Hospital ( Taipei , Taiwan ) in patients with dry eye syndrome who were r and omly assigned to 1 of 2 treatment groups : the carbomer-based lipid-containing ( CBLC ) gel group and the HP-guar gel group . The primary end point was global assessment of study treatment by the patients at weeks 2 and 4 . All patients met the diagnostic criteria of impaired tear function and ocular surface abnormalities . Outcomes measured at baseline and 2 and 4 weeks included Schirmer 's test values , tear breakup time ( TBUT ) , and a patient subjective assessment of symptoms . Safety and tolerability were assessed by clinical ly significant changes in terms of incidence of adverse events and conducted by unmasked investigators . RESULTS A total of 30 Taiwanese patients with dry eye syndrome were included and r and omly assigned to the 2 treatment groups : the mean ( SD ) age was 40.37 ( 14.96 ) years in the CBLC gel group and 49.49 ( 12.20 ) years in the HP-guar gel group . At baseline , the mean ( SD ) Schirmer 's test value was 4.53 ( 2.28 ) mm in the right eye and 5.13 ( 2.42 ) mm in the left eye in the CBLC gel group ; 4.40 ( 2.16 ) mm in the right eye and 4.20 ( 1.78 ) mm in the left eye for the HP-guar gel group . The mean ( SD ) for both eyes was 4.83 ( 2.36 ) mm in the CBLC gel group and 4.30 ( 2.08 ) mm in the HP-guar gel group . There was no statistically significant difference between Schirmer 's scores at baseline . Patients in both treatment groups experienced an improvement from baseline in symptoms and signs , Schirmer 's test value , and TBUT at 2 and 4 weeks after treatment . The Schirmer 's test score increased to a mean of 8.20 ( 4.49 ) mm in the right eye and 9.33 ( 4.94 ) mm in the left eye in the CBLC gel group after 2 weeks , and increased to 10.07 ( 5.56 ) mm in the right eye and 10.86 ( 5.58 ) mm in the left eye after 4 weeks . The increases in Schirmer 's test score and TBUT were also observed in the HP-guar gel group . The Schirmer 's test score increased to 5.13 ( 2.18 ) mm in the right eye and 5.60 ( 2.74 ) mm in the left eye after 2 weeks , and increased to 6.93 ( 3.37 ) mm in the right eye and 6.53 ( 3.16 ) mm in the left eye after 4 weeks . The increase in Schirmer 's test values in both eyes was significantly greater at 2 and 4 weeks in the CBLC gel group than that in the HP-guar gel artificial tear group ( all , P < 0.05 ) . Subjective patient assessment was better with the CBLC group ( excellent and good reported by 26.6 % and 73.4 % , respectively , of the CBLC gel group vs 13.4 % and 33.4 % of the HP-guar gel group at 4 weeks ; both , P = 0.004 ) . CONCLUSIONS Both artificial tear formulations were effective in relieving  dry eye syndrome in these patients . The tolerance of CBLC gel artificial tears was comparable to that of HP-guar gel artificial tears Dry eye is a common disorder in routine ophthalmological practice , and a better underst and ing of the complex pathophysiology is leading to improved treatment . Thealoz Duo ® is a novel artificial tear preparation containing two active ingredients : Trehalose , a naturally occurring disaccharide with anhydrobiotic functions in many organisms , and hyaluronate , a widely distributed anionic glycosaminoglycan polysaccharide with lubricative and water-retaining properties in biological systems . In a r and omized , single center , open label , crossover study , 17 adult patients with moderate-to-severe dry eye syndrome were r and omized to treatment with Thealoz Duo ® ( combining trehalose and hyaluronic acid ) or Systane ® . Patients received 7 days of treatment . The primary efficacy variable was patient satisfaction evaluated by a 0–100 visual analog scale evaluated on days 0 and 7 of treatment . Secondary parameters included ocular surface disease index ( OSDI ) , symptoms of dry eye , ocular staining scores ( fluorescein and lissamine green ) , ocular clinical signs , Schirmer test , tear breakup time , and global efficacy assessed by the patient and the investigator . Seventeen patients were included . Patient satisfaction improved from 44.5±19.0 to 70.2±19.2 mm during Thealoz Duo ® treatment and from 47.2±23 to 57.1±19.1 mm during Systane ® treatment ( P=0.043 , mixed-effects analysis of covariance ) . Two secondary efficacy parameters ( dry eye symptoms and the impact of their symptoms on work ) showed statistically significant advantages for Thealoz Duo ® over Systane ® . There were no statistically significant advantages for Systane ® over Thealoz Duo ® for any measured parameter . No adverse events were reported . Thealoz Duo ® appears to be an effective combination of two active ingredients for the treatment of dry eye and is at least as effective as Systane ® Purpose : To evaluate the clinical efficacy , retention rates , and complications of SmartPlug insertion compared with silicone punctal plugs in patients with dry eye . Methods : Thirty-six eyes with subjective symptoms of dry eye in addition to a tear film breakup time ( TBUT ) < 5 seconds and evidence of ocular surface damage on rose Bengal or fluorescein staining were included . Treated eyes were r and omized to either a silicone plug or SmartPlug inferior punctal occlusion . Pre- and posttreatment evaluations included subjective symptom scoring , tear meniscus height , TBUT , Schirmer test , fluorescein and rose Bengal staining , and artificial tear use . Results : After a mean follow-up period of 11.2 weeks , both the silicone plug- and SmartPlug-treated eyes showed significant improvement in symptom scoring ( P = 0.002 and P = 0.005 , respectively ) , TBUT ( P = 0.035 and P = 0.009 , respectively ) , and fluorescein ( P = 0.024 and P = 0.016 , respectively ) and rose Bengal ( P = 0.008 and P = 0.046 , respectively ) staining . There was no significant difference in these parameters between the 2 plugs . SmartPlug- , but not the silicone plug-treated eyes showed significant improvement in mean tear meniscus height ( P = 0.037 ) . The use of artificial tear supplements was reduced in 10 ( 55.6 % ) silicone- and 11 ( 61.1 % ) SmartPlug-treated eyes . Minor complications related to plug insertion were experienced in 4 ( 22 % ) silicone- and 2 ( 11 % ) SmartPlug-treated eyes . Spontaneous plug loss occurred with 6 ( 33 % ) silicone plugs . Conclusions : This prospect i ve r and omized trial shows that SmartPlug insertion has equivalent clinical efficacy to the use of conventional silicone plugs . Both SmartPlug and silicone plug use can reduce dependency on tear supplements in > 55 % of patients with dry eye Aims : To evaluate the efficacy of 50 % autologous serum drops against conventional treatment in ocular surface disorders refractory to normal treatments in a prospect i ve r and omised crossover trial . Method : Patients fulfilling ophthalmological and haematological entry criteria were r and omised to either 3 months of autologous serum 50 % followed by 3 months of their conventional treatment , or 3 months of conventional treatment , followed by 3 months of autologous serum . Clinical assessment s , including Schirmer ’s test , rose Bengal , and fluorescein staining , were carried out on entry and at monthly intervals . Impression cytology  was performed at entry , 3 and 6 months . Grading was carried out on degrees of squamous metaplasia and goblet cell density . Subjective comfort was recorded daily using the “ faces ” scale . These categorical scores were converted to linear measurement using Rasch analysis . Statistical analysis was carried out using Wilcoxon ’s signed rank test and ANOVA . Results : 16 patients were recruited with 31 eyes studied . The ocular surface diseases chiefly included Sjögren ’s syndrome ( n = 6 ) and keratoconjunctivitis sicca ( n = 5 ) . Impression cytology available in 25 of 31 eyes showed significant improvement on serum treatment , p<0.02 . Rasch weighted faces scores were statistically significantly better with serum , p<0.01 . Conclusion : The results of this r and omised study provide further evidence of the beneficial effects of autologous serum in severe ocular surface disorders . For most of these patients , autologous serum was superior to conventional treatment for improving ocular surface health and subjective comfort PURPOSE To evaluate the efficacy of autologous serum eye drops for  dry eye  after LASIK in a prospect i ve , r and omized study . METHODS Fifty-four eyes of 27 male patients who underwent LASIK were divided into two groups ; patients who used autologous serum eye drops and those who used artificial tears postoperatively .  Schirmer test with anesthesia , tear break-up time ( BUT ) , and rose bengal and fluorescein staining for the ocular surface were prospect ively compared between the groups . All values were also compared before and after surgery ( at 1 week [ except for Schirmer test ] , 1 month , 3 months , and 6 months ) in each group . RESULTS Tear BUT was greater in the autologous serum eye drops group than in the artificial tears group at 6 months postoperatively . Rose bengal score was lower in patients using autologous serum eye drops than in patients using artificial tears at 1 month and 3 months postoperatively . No significant difference was noted between patients using autologous serum eye drops and patients using artificial tears in the value of Schirmer test with anesthesia and fluorescein scores . In the autologous serum eye drops group , tear BUT was increased at 3 months after LASIK , rose bengal score was lower at 1 month and 3 months , and fluorescein score was lower at 1 month after LASIK compared to preoperative values , respectively . In the artificial tears group , all values ( Schirmer test , tear BUT , rose bengal score , and fluorescein score ) showed no differences between before and after LASIK . No differences were noted in the subjective scores for dryness between the autologous serum eye drops and artificial tears groups . CONCLUSIONS The autologous serum eye drops group showed prolongation of the tear BUT and a reduction in rose bengal staining score Purpose To evaluate the ability of Systane ® Balance ( SYSB ) administered four times per day for 4 weeks to increase noninvasive tear film break-up time ( NITFBUT ) over baseline compared with a saline ( SAL ) control in patients with lipid-deficient dry eye ( DE ) . Patients and methods Patients aged ≥18 years with DE and evidence of meibomian gl and dysfunction ( ie , abnormal gl and expression and missing meibomian gl and s ) were included in this r and omized , parallel-group , controlled , investigator-masked comparison study . Patients were r and omized to SYSB or SAL four times daily for 4 weeks . The primary efficacy variable was mean change in NITFBUT from baseline at week 4 . Ocular surface staining , goblet cell density , and meibomian gl and expression were also assessed . Safety assessment s included adverse events ( AEs ) , best-corrected visual acuity , and ocular signs . Results A total of 49 patients received study treatments ( SYSB , n=25 ; SAL , n=24 ) . Most patients were women ( 67.4 % ) and Caucasian ( 63.3 % ) ; mean ± st and ard deviation ( SD ) age was 44±19 years . DE characteristics at baseline were similar between groups . After 4 weeks of treatment , the mean ± SD NITFBUT increase from baseline was significantly greater with SYSB ( 2.83±0.74 seconds ) compared with SAL ( 0.66±0.55 seconds ; P<0.001 , t-test ) . Improvements in conjunctival and corneal staining , percentage of patients with increased goblet cell density , and meibomian gl and expression were also observed with 4 weeks of SYSB over SAL . No AEs were reported for either treatment group ; best-corrected visual acuity and ocular signs remained stable or improved compared with baseline . Conclusion SYSB restored tear film stability , improved ocular surface healing , and improved meibomian gl and functionality after 4 weeks of use in patients with lipid-deficient DE . No AEs were reported with either SYSB or SAL Purpose . To evaluate the efficacy of a new lubricant eye drop containing polyethylene glycol 400 and propylene glycol demulcents with hydroxypropyl-guar as a gelling agent ( Test Product ) to a system with carboxymethylcellulose ( Control Product ) for reducing dry eye signs and symptoms . Methods . Eighty-seven dry eye volunteers were enrolled at seven sites for this six-week , concurrently controlled , double-masked clinical study . Results . The Test Product significantly reduced conjunctival staining ( p = 0.025 ) and temporal corneal staining ( p = 0.024 ) compared to the Control . The Test Product also significantly reduced symptoms of dryness in the morning and evening , compared to the Control ( p = 0.015 and p = 0.023 , respectively ) . Subjects in the Test treatment group reported lower frequencies of foreign body sensation and felt their eyes were “ refreshed longer ” compared to those in the Control group ( p = 0.033 and p = 0.037 , respectively ) . Conclusions . The Test Product was more effective at reducing both the signs and symptoms of dry eye compared to the carboxymethylcellulose containing Control Purpose : To determine symptoms improvement in dry eye patients with short-term autologous serum ( AS ) eyedrops treatment using the st and ardized Ocular Surface Disease Index ( OSDI ) survey . Material s and methods : A double-blind r and omized crossover clinical trial was conducted , comparing short-term ( 2 weeks ) topical treatment with AS eyedrops diluted at 20 % versus conventional artificial tears treatment in adult severe dry eye syndrome ( DES ) patients . The main outcome measure was assessment of symptoms with OSDI survey . Secondary outcomes were corneal and conjunctival fluorescein staining score of OXFORD and tear break up time ( TBUT ) . The protocol was registered in www . clinical trials.gov , ID number : NCT00779987 . Results : Twelve severe DES patients were included .  Autologous serum treatment showed a statistically significant ( p = 0.002 ) higher OSDI decrease ( 50 % ) versus conventional treatment ( 22 % ) . There were no significant changes in objectives parameters ( OXFORD and TBUT ) . Conclusions : Severe DES patients treated with AS achieve better symptoms improvement compared to artificial tears in a short-term treatment OBJECTIVE To study the efficacy and safety of B cell depletion with rituximab , a chimeric murine/human anti-CD20 monoclonal antibody , in patients with primary Sjögren 's syndrome ( SS ) in a double-blind , r and omized , placebo-controlled trial . METHODS Patients with active primary SS , as determined by the revised American-European Consensus Group criteria , and a rate of stimulated whole saliva secretion of > or = 0.15 ml/minute were treated with either rituximab ( 1,000 mg ) or placebo infusions on days 1 and 15 . Patients were assigned r and omly to a treatment group in a ratio of 2:1 ( rituximab : placebo ) . Followup was conducted at 5 , 12 , 24 , 36 , and 48 weeks . The primary end point was the stimulated whole saliva flow rate , while secondary end points included functional , laboratory , and subjective variables . RESULTS Thirty patients with primary SS ( 29 female ) were r and omly allocated to a treatment group . The mean + /- SD age of the patients receiving rituximab was 43 + /- 11 years and the disease duration was 63 + /- 50 months , while patients in the placebo group were age 43 + /- 17 years and had a disease duration of 67 + /- 63 months . In the rituximab group , significant improvements , in terms of the mean change from baseline compared with that in the placebo group , were found for the primary end point of the stimulated whole saliva flow rate ( P = 0.038 versus placebo ) and also for various laboratory parameters ( B cell and rheumatoid factor [ RF ] levels ) , subjective parameters ( Multidimensional Fatigue Inventory [ MFI ] scores and visual analog scale [ VAS ] scores for sicca symptoms ) , and extragl and ular manifestations . Moreover , in comparison with baseline values , rituximab treatment significantly improved the stimulated whole saliva flow rate ( P = 0.004 ) and several other variables ( e.g. , B cell and RF levels , unstimulated whole saliva flow rate , lacrimal gl and function on the lissamine green test , MFI scores , Short Form 36 health survey scores , and VAS scores for sicca symptoms ) . One patient in the rituximab group developed mild serum sickness-like disease . CONCLUSION These results indicate that rituximab is an effective and safe treatment strategy for patients with primary SS Purpose : To investigate the potential effect of dietary supplementation with omega-3 fatty acid on lipid composition of meibum , aqueous tear evaporation , and tear volume in patients with dry eye . Methods : In a pilot , prospect i ve , r and omized , double-masked study , patients with dry eye received a daily dose of fish oil , containing 450 mg of eicosapentaenoic acid , 300 mg of docosahexaenoic acid , and 1000 mg of flaxseed oil ( TheraTears Nutrition ; Advanced Vision Research , Woburn , MA ) for 90 days . There were 2 patient visits : baseline and final . At these visits , patients completed the ocular surface disease index to score subjective symptoms , and slit-lamp examinations , breakup time , corneal staining , Schirmer type I , fluorophotometry , evaporometry , and collection of meibomian gl and secretion sample s for lipid composition analysis were performed . Results : A total of 36 patients with dry eye completed the study . At the end of the study , 70 % of the patients became asymptomatic , whereas for the placebo group , 7 % of the symptomatic patients became asymptomatic . Schirmer testing and fluorophotometry suggested that the omega-3 supplement increased tear secretion . The lipid composition of the sample s collected from the omega-3 group was found to be very similar to that from the placebo group . No trends between groups were seen for other objective parameters . Conclusions : Dietary supplementation with omega-3 fatty acids in dry eye showed no significant effect in meibum lipid composition or aqueous tear evaporation rate . On the other h and , the average tear production and tear volume was increased in the omega-3 group as indicated by both Schirmer testing and fluorophotometry Abstract Purpose : Dry eye is often characterized by increased tear evaporation due to poor tear film quality , especially of the lipid component of the tear film . Using an environmental chamber to induce environmental stress , this study compared the effect of three lubricant eye drops on various aspects of tear physiology in a crossover design ( evaporation was the principal outcome measure ) . Methods : Three eye drop formulas were tested : 0.5 % carmellose sodium ( Drop C ) , 0.5 % carmellose sodium with added lipid ( Drop C-L ) and 1.0 % glycerine with added lipid ( Drop G-L ) .  Nineteen control and 18 dry eye subjects used each product for 2 weeks , three times per day , in a r and om order , with a minimum 1-week washout between treatment periods . Tear evaporation , break up time , osmolarity , tear structure ( by interferometry ) and patient symptoms were assessed with the subjects adapted for 10 min in an environmental chamber controlled at 20 % relative humidity and 22 ° C . The treatment effects were analyzed using general linear model repeated measures analyses of variance . Results : In dry eye subjects , evaporation , break up time , osmolarity and symptoms improved for all formulas ( p < 0.05 ) . Normal subjects showed some improvements : evaporation with C-L , osmolarity with C and symptoms with C-L and G-L. Change in evaporation was greater for both C-L and G-L versus C ( p < 0.05 ) , and there was a trend for C-L to reduce evaporation more than G-L ( p < 0.11 ) . There were no significant treatment effects on tear film structure . Conclusion : Overall , the eye drop formula containing both carmellose sodium and lipid ( C-L ) produced a greater treatment effect on tear evaporation than the other formulations containing only one of these ingredients . This study also demonstrates the utility of a controlled environmental chamber in showing the difference in performance between dry eye treatments Purpose : To compare the efficacy of topical cyclosporine [ 0.05 % cyclosporine A ( CsA ) ] and preservative-free artificial tears in the treatment of meibomian gl and dysfunction ( MGD ) . Methods : A 3-month prospect i ve , r and omized , double-masked , parallel-group controlled trial enrolled 70 patients with symptomatic MGD and unstable tear film [ tear breakup time ( TBUT ) < 8 seconds ] . Patients were r and omized to topical CsA ( 0.05 % ; group A ) and 0.5 % carboxymethylcellulose ( control ; group B ) instilled twice daily for 3 months . Ocular Surface Disease Index ( OSDI ) , lid margin inflammation , meibomian gl and expression , conjunctival injection , corneal and interpalpebral dye staining , noninvasive tear breakup time ( NIBUT ) using the Tearscope Plus and invasive fluorescein tear breakup time ( FBUT ) , and Schirmer I test were performed . Results : At the 3-month evaluation , mean OSDI , NIBUT and FBUT , lid margin inflammation , meibomian gl and expressibility , and tarsal injection showed significant improvement from baseline in group A ( P < 0.01 , P < 0.01 , P < 0.001 , P < 0.05 , and P < 0.001 , respectively ) . In group B , only the OSDI improved significantly from baseline at 3 months ( P = 0.003 ) . TBUTs ( NIBUT and FBUT ) were significantly longer in group A at all visits , and the mean change of TBUTs from baseline was also significantly greater in group A at 3 months ( P < 0.001 ) . Conclusions : Topical CsA 0.05 % twice daily may be helpful in the treatment of MGD mainly by improving tear film stability Background / purpose Sjögren 's syndrome ( SS ) is characterized by diminished exocrine secretions with the result ant symptoms of dry mouth and dry eye . As genetic predisposition and ethnicity may alter the effectiveness of drug treatment , evaluation of the efficacy and safety of the secretagogue pilocarpine hy-drochloride in the treatment of xerostomia in patients with SS in different population s is needed . Methods Forty-four patients with SS were enrolled in this double-blind , placebo-controlled trial . Patients were r and omized to receive 5 mg pilocarpine ( Salagen ) or placebo tablet four times daily for 12 weeks . Global evaluation and subjective responses of patients were assessed by question naires with visual analog scales and categorical checkboxes . Saliva production was also measured by modified Saxon 's test . Results Pilocarpine treatment significantly improved global assessment of dry mouth , symptoms associated with dry mouth ( mouth comfort , ability to sleep and ability to speak ) , and saliva production compared to placebo . The drug was well tolerated and the most common adverse effect was sweating ( 5/23 , 21.7 % ) result ing from the muscarinic agonist action of the drug . No serious drug-related adverse effect was found in this study . Conclusion The results of this study suggest that therapy with 5 mg pilocarpine four times daily is effective , safe and well tolerated for the relief of oral symptoms in patients with SS in Taiwan Dry eye is a common condition that can severely impair the quality of life . We aim ed to find out whether oral sea buckthorn ( SB ) oil , containing ( n-3 ) and ( n-6 ) fatty acids and antioxidants , affects dry eye . In this double-blind , r and omized , parallel trial , 20- to 75-y-old women and men experiencing dry eye symptoms consumed 2 g of SB or placebo oil daily for 3 mo from fall to winter . One hundred participants were recruited and 86 completed the study . Clinical dry eye tests and symptom follow-ups were performed . Tear film hyperosmolarity is a focal factor in dry eye . There was a general increase in the osmolarity from baseline to the end of the intervention . Compared with the placebo group , the increase was significantly less in the SB group when all participants were included [ intention to treat ( ITT ) , P = 0.04 ] and when only participants consuming the study products for at least 80 % of the intervention days were included [ per protocol ( PP ) , P = 0.02 ] . The maximum intensities of redness and burning tended to be lower in the SB group . In the ITT participants , the group difference was significant for redness ( P = 0.04 ) but not for burning ( P = 0.05 ) . In the PP participants , the group difference was significant for burning ( P = 0.04 ) but not for redness ( P = 0.11 ) . In conclusion , SB oil attenuated the increase in tear film osmolarity during the cold season and positively affected the dry eye symptoms PURPOSE To evaluate if oral flaxseed oil ( Linum usitatissimum ) , which reduces the inflammation in rheumatoid arthritis , may help keratoconjunctivitis sicca 's treatment in Sjögren 's syndrome patients . METHODS In a r and omized clinical trial , 38 female patients with rheumatoid arthritis or systemic lupus erithematosus associated with keratoconjunctivitis sicca and Sjögren 's syndrome were consecutively selected from patients of the Department of Rheumatology of the Amazonas University Hospital . Keratoconjunctivitis sicca diagnosis was based on a dry-eye symptom survey score ( Ocular Surface Disease Index - OSDI ) , Schirmer-I test , fluorescein break-up time , 1 % Rose Bengal staining of ocular surface measured by the van Bijsterveld scale .  All patients had ocular surface inflammation evaluated and quantified by conjunctival impression cytology , before and after the study . The subjects were divided into three groups with 13 ( Group I ) , 12 ( Group II ) and 13 ( Group III ) patients . Group I received flaxseed oil capsules with a final 1 g/day dosis , Group II flaxseed oil capsules with a final 2 g/day dosis and Group III - controls - placebo , for 180 days . RESULTS Comparing the results at the beginning and at the end of the treatment , statistically significant changes ( p<0.05 ) in symptoms ( OSDI ) , ocular surface inflammation quantified by conjunctival impression cytology , Schirmer-I test and fluorescein break-up time occurred in Groups I e II when compared to controls . CONCLUSIONS Therapy with oral flaxseed oil capsules 1 or 2 g/day reduces ocular surface inflammation and ameliorates the symptoms of keratoconjunctivitis sicca in Sjögren 's syndrome patients . Long-term studies are needed to confirm the role of this therapy for keratoconjunctivitis sicca in Sjögren 's syndrome Background Dry eye may be caused or exacerbated by deficient lipid secretion . Recently , lipid-containing artificial tears have been developed to alleviate this deficiency . Our study compared the efficacy , safety , and acceptability of lipid-containing eye drops with that of aqueous eye drops . Methods A non-inferiority , r and omized , parallel-group , investigator-masked multicenter trial was conducted . Subjects with signs and symptoms of dry eye were r and omized to use one of two lipid-containing artificial tears , or one of two aqueous artificial tears . Subjects instilled assigned drops in each eye at least twice daily for 30 days . The primary efficacy analysis tested non-inferiority of a preservative-free lipid tear formulation ( LT UD ) to a preservative-free aqueous tear formulation ( AqT UD ) for change in Ocular Surface Disease Index ( OSDI ) score from baseline at day 30 . Secondary measures included OSDI at day 7 , tear break-up time ( TBUT ) , corneal and conjunctival staining , Schirmer ’s test , acceptability and usage question naires , and safety assessment s. Results A total of 315 subjects were r and omized and included in the analyses . Subjects reported instilling a median of three doses of study eye drops per day in all groups . At days 7 and 30 , all groups showed statistically significant improvements from baseline in OSDI ( P<0.001 ) and TBUT ( P≤0.005 ) . LT UD was non-inferior to AqT UD for mean change from baseline in OSDI score at day 30 . No consistent or clinical ly relevant differences for the other efficacy variables were observed . Acceptability was generally similar across the groups and there was a low incidence of adverse events . Conclusion In this heterogeneous population of dry eye subjects , there were no clinical ly significant differences in safety , effectiveness , and acceptability between lipid-containing artificial tears and aqueous eye drops . The results suggest that lipid-containing artificial tears can be used to counteract lipid deficiency that is common in dry eye , without compromising overall acceptability OBJECTIVE To evaluate cyclosporine 0.1 % ophthalmic emulsion over a 1- to 3-year period in moderate to severe dry eye disease patients . DESIGN Nonr and omized , multicenter , open-label clinical trial extending 2 ophthalmic cyclosporine phase III clinical trials . PARTICIPANTS Four hundred twelve patients previously dosed for 6 to 12 months with cyclosporine 0.05 % or 0.1 % in prior phase III trials . INTERVENTION Patients instilled ophthalmic cyclosporine 0.1 % twice daily into both eyes for up to 3 consecutive 12-month extension periods . MAIN OUTCOME MEASURES Corneal staining , Schirmer tests , and symptom severity assessment s were conducted during the first 12-month extension , with a patient survey during the second 12-month extension . Biomicroscopy and visual acuity ( VA ) examinations , intraocular pressure ( IOP ) measurements , and adverse effects queries occurred at 6-month intervals . RESULTS Mean duration of treatment was 19.8 months . Improvements in objective and subjective measures of dry eye disease were modest , probably because of prior treatment with cyclosporine . Most survey respondents said their symptoms began to resolve in the first 3 months of cyclosporine treatment during the previous phase III clinical trials . At study exit , VA decreased in 12.6 % ( 93/738 ) and increased in 5.4 % ( 40/738 ) of eyes by > or = 2 lines ; severity of biomicroscopy findings increased in 3.4 % ( chemosis ; 26/760 ) , 7.2 % ( conjunctival hyperemia ; 55/760 ) , or 8.5 % ( tear film debris ; 64/756 ) of eyes ; and mean IOP increased 0.18 mmHg relative to baseline . The most common treatment-related adverse events were burning ( 10.9 % of patients [ 45/412 ] ) , stinging ( 3.9 % [ 16/412 ] ) , and conjunctival hyperemia ( 3.4 % [ 14/412 ] ) . No serious treatment-related adverse events occurred . Most patients ( 95.2 % [ 140/147 ] ) said they would continue cyclosporine therapy ; 97.9 % ( 143/146 ) would recommend it to other dry eye patients . CONCLUSIONS Therapy of chronic dry eye disease with cyclosporine 0.1 % ophthalmic emulsion for 1 to 3 years was safe , well tolerated , and not associated with systemic side effects . The results supplement the safety record of the commercially available cyclosporine 0.05 % ophthalmic emulsion PURPOSE To determine the effect of oral omega-6 essential fatty acids on PGE(1 ) tear content and signs and symptoms of ocular discomfort in patients with Sjögren 's syndrome ( SS ) . METHODS This r and omized , double-masked , controlled , clinical trial involved 40 patients with primary SS , divided into two groups : group 1 : 20 patients ( 18 women , 2 men ; mean age , 36.9 + /- 7.9 years [ SD ] ) treated for 1 month with linoleic acid ( LA ; 112 mg ) , and gamma-linolenic acid ( GLA ; 15 mg ) administered twice daily ; group 2 : 20 patients ( 19 women , 1 man ; mean age , 36.3 + /- 5.5 years ) treated twice daily with placebo . Patients underwent three examinations : at baseline ( T0 ) , after 1 month of treatment ( T1 ) , and 15 days after suspension of treatment ( T2 ) . At each examination , the following tests were performed : tear sampling ( 2 microL ) from the inferior meniscus , tear break-up time ( BUT ) , fluorescein stain of the ocular surface , and tear basal secretion . A symptom score was also obtained at each examination . PGE1 was evaluated by enzyme immunoassay . The primary efficacy variable was PGE1 content of tears . RESULTS The tear PGE1 levels were significantly increased in group 1 at T1 versus T0 ( PGE1 level : T0 , 44 + /- 5.4 ng/mL ; T1 , 58.3 + /- 5.5 ng/mL ; P < 0.01 versus T0 and group 2 at T1 ) . At examination T2 , a statistically significant reduction of PGE1 levels toward baseline was observed ( 45.7 + /- 5.2 ng/mL ; P < 0.01 versus T1 ) . A statistically significant reduction of symptom score was observed in group 1 at examination T1 ( P < 0.01 versus T0 and group 2 score ) . At examination T2 , the symptom score was significantly higher than T1 but remained lower than T0 . The corneal fluorescein stain in group 1 showed a statistically significant improvement at examination T1 versus T0 and group 2 ( P < 0.01 ) . This improvement was also present at T2 ( P < 0.02 ) . No statistically significant differences were found for the other tests . No statistically significant changes were observed in the patients in group 2 at all examination time points . CONCLUSIONS Omega-6 administration increases the PGE1 levels in tears of patients with SS and improves ocular surface signs and symptoms of ocular discomfort Aims To compare the efficacy and safety of 3 % diquafosol ophthalmic solution with those of 0.1 % sodium hyaluronate ophthalmic solution in dry eye patients , using mean changes in fluorescein and rose bengal staining scores as endpoints . Trial design and methods In this multicenter , r and omised , double-masked , parallel study of 286 dry eye patients with fluorescein and rose bengal staining scores of ≥3 were r and omised to the treatment groups in a 1 : 1 ratio . Efficacy and safety were evaluated after drop-wise instillation of the study drug , six times daily for 4 weeks . Results After 4 weeks , the intergroup difference in the mean change from baseline in fluorescein staining score was −0.03 ; this verified the non-inferiority of diquafosol . The mean change from baseline in rose bengal staining score was significantly lower in the diquafosol group ( p=0.010 ) , thus verifying its superiority . The incidence of adverse events was 26.4 % and 18.9 % in the diquafosol and sodium hyaluronate groups , respectively , with no significant difference . Conclusions Diquafosol ( 3 % ) and sodium hyaluronate ( 0.1 % ) exhibit similar efficacy in improving fluorescein staining scores of dry eye patients , whereas , diquafosol exhibits superior efficacy in improving rose bengal  staining scores . Diquafosol has high clinical efficacy and is well tolerated with a good safety profile Purpose To evaluate and compare the efficacy and safety of two investigational artificial tear formulations ( CHO-1 and CHO-2 ) containing carmellose sodium , hyaluronic acid at different concentrations , and osmoprotectants , with a st and ard carmellose sodium-containing formulation ( Refresh Tears [ RT ] ) in the treatment of dry eye disease . Subjects and methods In this 3-month , double-masked , multicenter study , subjects ( n=305 ) were r and omized 1:1:1 to receive CHO-1 , CHO-2 , or RT , used as needed but at least twice daily . The primary endpoint was change in ocular surface disease index ( OSDI ) score from baseline to day 90 . Other key outcomes included symptoms evaluated on a visual analog scale , corneal and conjunctival staining , and adverse events . Results OSDI scores and dry eye symptoms showed a rapid and sustained reduction from baseline in each group . Both CHO-1 and CHO-2 met the primary efficacy endpoint of noninferiority to RT in day 90 OSDI score change from baseline . OSDI ocular symptoms subscale improved more with CHO-1 than CHO-2 ( P=0.048 ) . In subjects with clinical ly relevant baseline ocular surface staining ( > 14 total score of a maximum of 55 ) , day 90 improvements were greater with CHO-1 and CHO-2 than RT ( P≤0.044 ) . Day 90 improvements in OSDI ocular symptoms subscale scores were also greater with CHO-1 than RT ( P<0.007 ) in subjects with clinical ly relevant ocular staining . All treatments were well tolerated . Conclusion Both combination artificial tear formulations were efficacious and well tolerated in subjects with dry eye . CHO-1 demonstrated the best performance in improving ocular symptoms and reducing ocular staining in this heterogeneous study population Purpose : A controlled uniocular study to evaluate the short-term efficacy of lacrimal punctum occlusion in the treatment of severe dry eye caused by Sjögren syndrome . Methods : Uniocular punctum occlusion by punctum plug in the upper and lower puncta in 1 eye was performed in 20 patients with severe keratoconjunctivitis Sicca caused by Sjögren syndrome . To overcome possible interindividual variability between patients , the other eye , in the same patient , was not occluded and served as a control eye . The eye to be occluded was r and omly selected . The patients were instructed to continue using their dry eye medications . Tear function tests ( Schirmer test , rose Bengal test , and debris in de cul-de-sac ) were performed in both eyes . Subjective complaints ( discomfort ) were registered for both eyes . All the above-mentioned data were collected before starting the treatment and at least 6 weeks later . The above-mentioned parameters were compared and statistically analyzed in both eyes . Results : Of the 20 patients , 7 patients dropped out . The remaining 13 patients completed the final analysis . In the occluded eye , we found a significant improvement in both the subjective complaints and the rose Bengal score , but the Schirmer test and the tear mucus score did not change . Conclusion : Punctum occlusion therapy in a short-term study improved the rose Bengal score and discomfort score in our patients and thus may be helpful in the treatment of severe dry eye caused by Sjögren syndrome Objective To investigate the efficacy of a novel ocular lubricant compared with a commercially marketed ocular lubricant in a group of noncontact lens wearers currently using over-the-counter products for the management of symptoms of moderate to severe dry eye . Methods This was a prospect i ve , double-masked study that r and omized 110 subjects in a ratio of 1:1 to receive a novel ocular lubricant ( test group ) or a marketed ocular lubricant ( control group ) . Subjects were instructed to instill the lubricant eye drops at least three times daily . After enrollment , subjects were evaluated at baseline and at 7 and 30 days . They were also required to complete a series of home-based subjective question naires after 15 days . Main outcomes were subjective symptoms and objective clinical assessment at 7 and 30 days . Results The test group had higher overall comfort ratings than the control group ( P = 0.012 ) . Seventy-one percent of the test group and 57 % of the control group said the drops used “ somewhat ” or “ definitely ” improved ocular comfort ; 62 % of the test group had greater end-of-day comfort compared with 45 % of the control group ( P = 0.015 ) . There were no between-group differences in visual acuity , tear quality or quantity , corneal staining , conjunctival staining , or bulbar and limbal conjunctival hyperemia . Conclusions The novel ocular lubricant offers equivalent or superior comfort compared with a marketed lubricant eye drop . Objective clinical outcomes were not statistically significantly different between the two groups PURPOSE The goals of this study were to compare the efficacy and safety profile of topical cyclosporine 0.05 % versus vehicle in Chinese patients with moderate to severe dry eye disease . METHODS In this multicenter , r and omized , double-blind , vehicle-controlled , parallel-group study , 233 dry eye patients were allocated to receive either cyclosporine 0.05 % or vehicle twice daily for 8 weeks . Primary outcome was the difference between groups , in total score of 4 symptoms and 4 signs change from baseline at weeks 2 , 4 , and 8 . Changes in symptoms ( ocular dryness , foreign body sensation , photophobia and burning ) and signs ( conjunctival hyperemia , Schirmer test , tear Break-up time ( BUT ) , and corneal punctate fluorescein staining ) at weeks 2 , 4 , and 8 as well as frequency of administration of concomitant artificial tears , were considered as secondary outcomes . The safety profile was evaluated by examining adverse events , changes in visual acuity , and ocular tolerance . RESULTS Greater improvements of the total score were seen in cyclosporine 0.05 % group than in the vehicle group at all follow-up times ( P < 0.01 ) . Improvements in ocular dryness at week 8 ( P = 0.040 ) and foreign body sensation during weeks 4 and 8 ( P < 0.020 ) were significantly greater with cyclosporine . In addition , compared with the vehicle , cyclosporine significantly improved 2 objective dry eye disease signs : corneal staining at weeks 4 ( P = 0.025 ) and 8 ( P = 0.050 ) and the Schirmer test at week 4 ( P = 0.035 ) . However , no between-group difference approached statistical significance in photophobia , burning , BUT value , conjunctival hyperemia and frequency of administration of concomitant artificial tears at any follow-up times ( P > 0.05).The cumulative frequency of adverse events did not significantly differ between the groups ( P = 0.519 ) , which were 11.21 % and 8.55 % , respectively . There were no patients who experienced reduced visual acuity . CONCLUSION Cyclosporine 0.05 % ophthalmic emulsion is an effective and safe treatment for Chinese patients with moderate to severe dry eye disease Purpose . To assess the efficacy of cyclosporine 0.05 % ophthalmic emulsion ( Restasis ; Allergan , Inc. , Irvine , CA ) in the treatment of contact lens wearers with dry eyes . Methods . Contact lens wearers citing dry eye problems were identified through chart review . Participants were r and omly assigned to a treatment group , receiving vials of cyclosporine 0.05 % ophthalmic emulsion to use twice daily , or a placebo group , receiving vials of rewetting drops ( Refresh Preservative Free Artificial Tears ; Allergan , Inc. ) to use twice daily . Corneal staining , tear film breakup time , and Schirmer test results were documented at baseline and after 3 months . Participants also completed question naires , the Ocular Surface Disease Index , and the National Eye Institute Refractive Error Quality of Life Instrument at baseline and after 3 months . Results . For all parameters , including objective findings and subjective reporting of symptoms , there was no statistically significant difference between the treatment and placebo groups . Conclusions . This study did not detect a beneficial effect in using cyclosporine 0.05 % ophthalmic emulsion over rewetting drops for contact lens wearers . This may be attributable to the small sample size . It is also possible that the mechanism of the dry eye state in contact lens wearers may be different from that of other dry eye states and thus make cyclosporine 0.05 % ophthalmic emulsion an ineffective treatment BACKGROUND Most of the eye drops currently used replace only the aqueous phase of the tear film . But , due to the fact that , with approximately 80 % of the patients with a dry eye , a disturbance of the lipid phase is present , an approach for new treatment methods needed to be found . We examined a new therapy concept with an eye spray containing liposomes for the therapy of the " dry eye " in a long-term study . GOAL An examination of the effectiveness of a liposome eye spray ( TEARS AGAIN , Optima Pharmaceutical GmbH , Germany ) in patients with " dry eye " compared with a spray containing a balanced salt solution was carried out . METHODS Between August 2003 and May 2004 a double-blind study with 382 patients was accomplished . The treatment group ( V ; n = 191 ) was compared with the control group ( K ; n = 191 ) for a period of 6 months regarding the following examination criteria : eyelid edge parallel conjunctival folds ( LIPCOF ) , BREAK UP time ( BUT ) , Schirmer I test , best corrected visual acuity , as well as slit lamp findings of the cornea and conjunctiva . Follow-up was after 4 weeks and 6 months . The statistical analysis was performed with the statistical program SPSS v.11.5 . RESULTS The examined parameters such as LIPCOF , BUT and Schirmer were significantly better in the treatment group than in the control group . We found likewise significant improvements of the inflammations of the edge of eyelid with a remarkable decrease of around 89.5 % . Question ing of the patients result ed in , among other things , the belief that the liposome eye spray led altogether to a clear subjective improvement of the symptoms in 72 % of the cases , although an initial burning sensation was mentioned after the application . All patients were of the opinion that application with a spray is more favourably and more pleasant than teardrops . CONCLUSION The liposome tear substitute shows statistically significant advantages against a balanced salt solution . This new liposome eye spray represents a new , revolutionary and effective procedure in the therapy of the " dry eye " . Considering the disturbance of the lipid phase in 80 % of the patients , TEARS AGAIN ought to be a first choice treatment Objective : Primary Sjögren syndrome ( pSS ) causes significant systemic symptoms including fatigue as well as gl and ular dysfunction . There are currently no effective systemic therapies ; however , open label series have suggested that rituximab may be beneficial for systemic and gl and ular manifestations . Therefore , we performed a double blind , placebo-controlled , r and omised pilot study of the efficacy of rituximab in reducing fatigue in pSS . Methods : A total of 17 patients with pSS and a score on fatigue visual analogue scale ( VAS ) > 50 were r and omised to receive either 2 infusions of rituximab 1 g or placebo ; patients also received oral and intravenous steroids . Outcome measures included : the proportion of patients with > 20 % reduction in fatigue VAS , changes in pSS related symptoms , health related quality of life and immunological parameters of pSS . These were measured 6 months after therapy . Results : There was significant improvement from baseline in fatigue VAS in the rituximab group ( p<0.001 ) in contrast to the placebo group ( p = 0.147 ) . There was a significant difference between the groups at 6 months in the social functioning score of SF-36 ( p = 0.01 ) and a trend to significant difference in the mental health domain score of SF-36 ( p = 0.06 ) . There was one episode of serum sickness in the rituximab treated group . Conclusions : This is the first double blind study of rituximab in pSS to show benefit ; further studies are justified The purpose of this study was to evaluate the efficacy of fish oil supplementation added to usual dry eye treatment in dry eye subjects in a r and omized controlled trial . Twenty-seven typical dry eye subjects were selected from 43 c and i date s by the diagnostic criterion for dry eye in this study . They were assigned to the r and omized fish oil group ( n = 15 ) or the placebo group ( n = 12 ) . Fish oil group ingested fish oil capsules containing eicosapentaenoic acid ( EPA , 1245 mg/day ) and docosahexaenoic acid ( DHA , 540 mg/day ) for 12 weeks . Placebo group ingested placebo capsules without EPA or DHA . A visual analog scale test estimating subjective symptoms , the Schirmer I test , tear film break-up time ( BUT ) measurement , fluorescein staining , and rose bengal staining were performed every 4 weeks during the 12-week supplementation period and 4-week washout period . The subjective symptom of " eye pain " , BUT , and changes in rose bengal staining score of the fish oil group were significantly improved after 8 - 12 weeks of supplementation and /or 4 weeks of washout , compared to those of the placebo group . These results suggest that fish oil supplementation added to usual care may be effective in the treatment of dry eye Introduction Because of the added emphasis on ocular surface damage included in the Dry Eye Workshop ’s revised definition of dry eye , an evaluation of corneal staining reductions was conducted for propylene glycol/polyethylene glycol 400-based artificial tear drops ( Systane ® Lubricant Eye Drops ; Alcon Laboratories , Fort Worth , TX , USA ) . Methods An analysis was conducted on the percent change from baseline in mean corneal staining scores as reported in two previously published , r and omized , double-masked , 6-week clinical studies of Systane . A descriptive comparison was also made between the outcome of the composite analysis and data obtained for Optive ™ Lubricant Eye Drops ( Allergan , Inc. , Irvine , CA , USA ) . Finally , results were review ed for an open-label study that investigated corneal staining over a 5-week period after patients discontinued Systane therapy . Results The composite analysis included 107 Systane-treated patients . The results showed that Systane consistently reduced corneal staining at each visit ; the percent change from baseline to day 42 ( exit ) was 47.1 % ( P<0.0001 ) . After discontinuing Systane , immediate and significant increases in corneal staining were reported by 20 patients , with an overall increase from baseline to day 35 ( exit ) of 195.0 % ( P<0.0001 ) . Conclusion Evaluations of sum corneal ocular staining scores provide clinical ly meaningful evidence of dry eye severity , and are an important indicator of dry eye disease progression . The results of the composite analysis of two peer- review ed studies indicate that Systane significantly reduced corneal staining ( P<0.0001 ) , indicating a reduction in the severity of dry eye . Finally , discontinuation of Systane results in a rapid increase in corneal staining that further confirms Systane ’s ability to maintain ocular surface health Purpose : To compare the efficacy of topical cyclosporine , punctal occlusion , and a combination for the treatment of dry eye  .  Methods : Patients with dry eye ( N = 30 ) seen in a university-affiliated private practice were r and omized to 1 of 3 treatments : cyclosporine 0.05 % ophthalmic emulsion ( RESTASIS ) twice daily , lower-lid punctal plugs ( PARASOL ) , or a plugs-cyclosporine combination .  Tear volume , ocular surface staining , and artificial tear use were assessed at baseline and 1 , 3 , and 6 months . Results : All treatments improved Schirmer scores by 6 months ( P ≤ 0.005 vs. baseline ) , with plug-containing regimens favored at 1 and 3 months ( P < 0.001 vs. cyclosporine alone ) . Cyclosporine-containing regimens , but not plugs alone , improved rose bengal staining at 3 and 6 months ( P ≤ 0.010 vs. baseline ) . Artificial tear use decreased with plug-containing regimens at 1 month and with all treatments at 3 and 6 months ( P ≤ 0.005 vs. baseline ) . Combination therapy produced the greatest overall improvements and was superior to plugs alone in decreasing artificial tear use at 6 months ( P = 0.012 ) . Conclusions : All 3 regimens effectively treated dry eye . Plug-containing regimens increased wetness initially ; cyclosporine appeared to promote long-term ocular surface health . The effects may be additive . Patients with punctal occlusion may benefit from adjunctive cyclosporine OBJECTIVE To evaluate safety and efficacy of topical ophthalmic tofacitinib ( CP-690,550 ) , a novel Janus kinase inhibitor , in treating dry eye disease ( DED ) . DESIGN A phase 1/2 prospect i ve , r and omized , double-masked , multicenter , vehicle- and comparator-controlled trial ( NCT00784719 ) . PARTICIPANTS Patients ( n = 327 ) 18 years of age and older with a DED diagnosis for 6 months or more . METHODS Tofacitinib ( 0.0003 % twice daily , n = 46 ; 0.001 % in both eyes twice daily , n = 47 ; 0.003 % twice daily , n = 48 ; 0.005 % twice daily , n = 48 ; 0.005 % once daily , n = 44 ) results were compared with those of groups receiving active treatment cyclosporine ophthalmic emulsion 0.05 % twice daily ( n = 47 ) and vehicle twice daily ( n = 47 ) . Safety and efficacy evaluations were performed at baseline and throughout the 8-week study . MAIN OUTCOME MEASURES Schirmer wetting , corneal staining , tear film break-up time , conjunctival staining , Ocular Comfort Index ( OCI ) , and Ocular Surface Disease Index ( OSDI ) . RESULTS All tofacitinib doses were well tolerated , exhibiting better patient-reported ocular tolerability than cyclosporine . For the proportion of patients achieving 10 mm or more Schirmer wetting ( without anesthesia ) at week 8 ( primary end point ) , greater response rates were observed in the tofacitinib 0.001 % twice daily ( 27.3 % ) , 0.005 % twice daily ( 25.5 % ) , and 0.005 % once daily ( 26.1 % ) groups versus vehicle ( 20.0 % ) ; however , the differences were not statistically significant . Mean increase in Schirmer wetting ( without anesthesia ) from baseline was statistically significant ( P<0.2 , 2-sided ) for all tofacitinib doses ( 1.7 - 3.1 mm ) , cyclosporine ( 3.9 mm ) , and vehicle ( 1.4 mm ) . For corneal staining ( total score ) , significant improvement ( reduction ) from baseline was observed for all tofacitinib doses ( -0.9 to -1.9 ) and vehicle ( -2.0 ) , but not for cyclosporine . The proportion of patients with complete corneal clearing ( CCC ; 100 % ) at week 8 was greatest with tofacitinib 0.005 % once daily ( 15.9 % ) versus vehicle ( 6.7 % ) . Symptom scores ( OCI , OSDI ) at week 8 showed significant improvements from baseline for all tofacitinib groups , and tofacitinib demonstrated greater improvements than cyclosporine . The tofacitinib 0.005 % once daily group showed significant improvements in both a sign ( Schirmer wetting without anesthesia ) and symptom ( OSDI environmental triggers subscale ) versus vehicle and also demonstrated the highest response rate for CCC ( 16.7 % ) at week 8 . CONCLUSIONS This phase 1/2 study of tofacitinib demonstrated a trend for improving both signs and symptoms of dry eye . All doses of tofacitinib exhibited a reasonable safety profile and were well tolerated by patients with DED PURPOSE To compare the short-term efficacy of collagen and silicone plugs for treating dry eye using quantitative lacrimal scintigraphy . DESIGN Prospect i ve r and omized clinical trial . METHODS In this institutional study , 24 dry eye patients were evaluated in two groups : group I ( n = 22 eyes ) received collagen plugs and group II ( n = 26 eyes ) received silicone plugs . Comparisons were made with normal control subjects ( n = 22 eyes ) . Data for the Schirmer I test , tear break-up time , and ocular surface staining with rose bengal dye were recorded before and after punctal occlusion . Lacrimal scintigraphy was performed at each time point , and the time to half maximum activity on the ocular surface ( T(1/2 ) ) , and the percentage retention of activity on the ocular surface at the end of the dynamic study ( RI ) were recorded . RESULTS In both patient groups , Schirmer I results , tear break-up times , and rose bengal staining scores improved significantly after plug insertion . Mean T(1/2 ) values and RI values increased significantly in both groups ( P < .0001 for both ) . The differences for these values between groups I and II was statistically insignificant ( P > .05 ) . CONCLUSIONS Collagen and silicone plugs both result ed in significant increases in aqueous tear volume , half-life of nuclear material on the ocular surface , and percentage of nuclear material retention . The groups ' post-insertion values for all parameters were similar . These results suggest that these two plug types have similar efficacy as treatments for dry eye in the short term . Further studies evaluating long-term results are required Objective To evaluate the efficacy and safety of two different concentrations of cyclosporine A ( CsA ) in aqueous solution compared to vehicle in patients with dry eye syndrome . Design Multicentre , r and omised , double-masked , vehicle-controlled , clinical trial . Methods A total of 183 patients were enrolled and r and omised to either CsA 1 % ( group A ) , CsA 0.05 % ( group B ) or vehicle only ( group C ) . The main objective was to evaluate the efficacy of CsA aqueous solution in the reduction of signs and symptoms in patients with moderate to severe dry eye disease .  Results An early ( day 21 ) statistically significant improvement ( p<0.05 ) was evident in four symptoms and three ocular signs in group A. An equivalent improvement in three symptoms and three ocular signs was demonstrated in group B. A significant improvement was identified in two symptoms and two ocular signs in group C. Comparing the three groups together , group A performed better in four symptoms than group B did with just one symptom . Group C did not show significant improvement . At day 42 , group A showed improvement in four symptoms , while group B showed improvement in one symptom and one ocular sign . Conclusions Cyclosporine A reduced complaints and improved major ocular signs in patients with moderate-to-severe dry eye disease . The group treated with the 0.1 % cyclosporine A aqueous solution outperformed the other groups Purpose : To evaluate the effect of decreasing topical cyclosporine 0.05 % ( tCSA ) ( Restasis ; Allergan , Irvine , CA ) from twice-daily dosing to once-daily dosing in patients who have already completed 12 months of twice-daily therapy for dry eye disease . Design : Prospect i ve , r and omized , single-masked , parallel group comparison . Participants : One hundred patients who had already been treated with tCSA twice daily for more than 1 year were r and omized either to continue tCSA twice daily ( n = 50 ) or to decrease tCSA once daily ( n = 50 ) . Methods : Clinical measurement of dry eye variables was performed for all patients at baseline , 3 months , and 6 months . Mean data were used for within-group ( longitudinal analysis ) and between-group comparisons ( once daily vs. twice daily ) . Main Outcome Measures : Fluorescein tear break-up time , corneal fluorescein staining score , lissamine green staining score , Schirmer tear test , and ocular surface disease index . Results : At the end of the study , patients whose treatment dose was decreased to once daily demonstrated statistically significant improvement in tear break-up time [ 4.13 seconds ( n = 37 ) vs. 3.11 seconds at baseline ( n = 50 ) ; P = 0.0003 ] and lissamine green staining score [ 4.42 ( n = 37 ) vs. 6.51 at baseline ( n = 50 ) ; P = 0.024 ] ; fluorescein staining score , Schirmer test results , and ocular surface disease index did not change significantly ( P > 0.05 ) . Furthermore , the once-daily group demonstrated significantly superior ocular surface disease index compared with the twice daily group [ 15.91 ( n = 37 ) vs. 22.62 ( n = 48 ) ; P = 0.0496 ] . The remaining outcome measures between once daily and twice daily were not significantly different ( P > 0.05 ) . Seven of 50 patients ( 14 % ) in the once-daily group ( vs. 0 % in the twice-daily group ) ended the study early because of worsening dry eye symptoms ( P < 0.05 ) and went back to twice-daily dosing . Conclusions : For patients with dry eye that has been controlled with tCSA twice daily for at least 1 year , decreasing to tCSA once daily may still allow suppression of the dry eye disease OBJECTIVE To investigate the dose-dependent efficacy and safety of diquafosol ophthalmic solution for the treatment of dry eye syndrome . DESIGN R and omized , double-masked , multicenter , parallel-group , placebo-controlled trial . PARTICIPANTS A total of 286 Japanese patients with dry eye who were prescribed topical diquafosol ( 1 % , n = 96 ; 3 % , n = 96 ) or placebo ophthalmic solution ( n = 94 ) . METHODS After a washout period of 2 weeks , qualified subjects were r and omized to receive a single drop of 1 % or 3 % diquafosol or placebo ophthalmic solutions 6 times per day for 6 weeks . MAIN OUTCOME MEASURES The primary outcome measure was fluorescein corneal staining score assessment . The secondary outcome measures were Rose Bengal corneal and conjunctival staining scores , tear break-up time ( BUT ) , and subjective symptom assessment . Safety measures were clinical blood and urine examination and recording of adverse events . RESULTS Fluorescein corneal staining scores significantly improved with both 1 % and 3 % topical diquafosol compared with placebo at 4 weeks , respectively ( P = 0.037 , P = 0.002 ) . There was a dose-dependent effect among the groups . Rose Bengal corneal and conjunctival staining scores also improved significantly with both 1 % and 3 % diquafosol compared with placebo ( P = 0.007 and P = 0.004 , respectively ) . Subjective dry eye symptom scores significantly improved with both diquafosol ophthalmic solutions ( P ≤ 0.033 ) , although there were no significant differences in BUT compared with placebo . No significant differences between the treatment groups were observed in relation to the occurrence of adverse events . CONCLUSIONS Both 1 % and 3 % diquafosol ophthalmic solutions are considered effective and safe for the treatment of dry eye syndrome PURPOSE To evaluate loteprednol etabonate ophthalmic 0.5 % suspension , versus placebo for treatment of the inflammatory component of keratoconjunctivitis sicca in patients with delayed tear clearance .  DESIGN R and omized , double-masked , placebo-controlled clinical trial . METHODS Sixty-four patients with keratoconjunctivitis sicca and delayed tear clearance were r and omly assigned to receive either loteprednol or vehicle 4 times a day for 4 weeks . Patients were evaluated at weeks 2 and 4 of treatment and 2 weeks after treatment was discontinued . Symptoms were scored using a visual analog scale ( VAS ) of 1 to 100 . Corneal fluorescein staining was scored 0 to 4 in five areas . Conjunctival injection was grade d 0 to 3 in the inferior bulbar , nasal bulbar , and inferior tarsal areas . Lid margin injection was grade d 0 to 3 . Safety was assessed by funduscopy , lens examination , biomicroscopy , visual acuity , and Goldmann tonometry , and by monitoring adverse events and changes in symptoms . RESULTS In subsets of patients with at least moderate clinical inflammation , there was a significant difference between the loteprednol-treated group and vehicle-treated group after 2 weeks of therapy . The differences did not reach statistical significance at 4 weeks , although the loteprednol-treated patients retained their improvement compared with the vehicle-treated group . Safety evaluations showed both treatments to be well tolerated and similar in the frequency and type of adverse event reported . CONCLUSION The use of topical loteprednol etabonate 0.5 % 4 times a day may be beneficial in patients who have keratoconjunctivitis sicca with at least a moderate inflammatory component OBJECTIVE This pilot study evaluated the effect of anti-tumor necrosis factor-a antiinflammatory treatment with etanercept ( Enbrel(R ) ) on sicca , systemic , and histological signs in patients with primary Sjögren 's syndrome ( SS ) . METHODS Fifteen patients with well defined primary SS were treated with 25 mg etanercept subcutaneously twice per week during 12 weeks , with followup visits at Weeks 18 and 24 . Evaluation measures included a Multidimensional Fatigue Inventory ( MFI ) question naire , serological monitoring , salivary flow tests , Schirmer test , rose bengal cornea staining , and tear film breakup time . A sublabial minor salivary gl and biopsy was performed at baseline and at Week 12 and lymphocytic focus score and percentage IgA-containing plasma cells ( IgA% ) were assessed . RESULTS No increase of salivary or lachrymal gl and function was observed in any participant . In 4 patients a decrease of fatigue complaints was noted , which was also reflected by decreased scores in the MFI question naire . Reduced erythrocyte sedimentation rate was observed in 3 of 4 patients with reduced fatigue . No significant change of lymphocyte focus score or IgA% was observed . A repeated treatment up to 26 weeks showed the same results . CONCLUSION A 12-week or prolonged treatment of etanercept 25 mg twice weekly did not appear to reduce sicca symptoms and signs in SS . However , etanercept treatment may be beneficial in a small subgroup of SS patients with severe fatigue . Etanercept 25 mg twice weekly did not affect minor salivary gl and biopsy results PURPOSE : To evaluate dry‐eye signs , symptoms , and refractive outcomes in patients with dry‐eye disease having laser in situ keratomileusis ( LASIK ) . METHODS : In this r and omized parallel double‐masked prospect i ve clinical trial , 42 eyes of 21 myopic patients ( mean spherical equivalent −4.3 diopters [ D ] , range −1.00 to −10.63 D ) with dry‐eye disease were treated with unpreserved artificial tears or cyclosporine 0.05 % ophthalmic emulsion twice a day beginning 1 month before LASIK . Treatment with the study drug was discontinued for 48 hours post surgery and then resumed for 3 additional months . Both groups used additional artificial tears as needed . Study visits occurred pretreatment ( baseline ) , before surgery , and at 1 week and 1 , 3 , 6 , and 12 months after surgery . RESULTS : Statistically significant increases from baseline were found in Schirmer scores for artificial tears at 1 month ( P = .036 ) and for cyclosporine 0.05 % before surgery and 1 week , 1 month , and 6 months after surgery ( P<.018 ) . There were no significant differences from baseline or between groups in responses to the Ocular Surface Disease Index question naire or best corrected visual acuity ( BCVA ) , nor were there significant between‐group differences in superficial punctate keratitis or uncorrected visual acuity . Mean refractive spherical equivalent in cyclosporine‐treated eyes was significantly closer to the intended target at 3 and 6 months after surgery than in artificial‐tears – treated eyes ( P = .007 ) . A greater percentage of cyclosporine eyes was within ±0.5 D of the refractive target 3 months after surgery than artificial tears eyes ( P = .015 ) . CONCLUSION : Successful outcomes after LASIK were achieved for dry‐eye disease patients . Treatment with cyclosporine 0.05 % provided greater refractive predictability 3 and 6 months after surgery than unpreserved artificial tears Purpose : To investigate the safety and efficacy of diquafosol tetrasodium , a P2Y2 receptor agonist that stimulates fluid and mucin secretion on the ocular surface , as a novel topical treatment of dry eye disease . Methods : Subjects with dry eye ( n = 527 ) were evaluated in a r and omized , double-masked , parallel-group trial comparing 24 weeks of treatment with 2 concentrations of diquafosol ( 1 % and 2 % ) versus placebo instilled 4 times daily . Corneal staining , conjunctival staining , Schirmer tests , and subjective symptoms of dry eye were evaluated . Use of artificial tears was permitted as necessary . Results : Subjects treated with 2 % diquafosol had significantly lower corneal staining scores compared with placebo at the 6-week , primary efficacy time point ( P < 0.001 ) , and superiority continued throughout the 24-week study . Reductions in corneal staining were observed as early as after 2 weeks of treatment , were maintained throughout the 24-week study , and were observed to worsen slightly ( toward baseline ) when diquafosol treatment was discontinued ( week 25 ) . Results for conjunctival staining were consistent with those observed for corneal staining . Schirmer scores at week 6 were significantly higher with diquafosol treatment than with placebo ( P \H 0.030 ) . The percentage of subjects with clearing of foreign body sensation ( score of 0 ) was higher at week 6 in subjects treated with 2 % diquafosol ( 21 % ) compared with placebo ( 15 % ) , but the difference did not achieve significance ( P = 0.193 ) . Significant differences in favor of diquafosol were observed for clearing of foreign body sensation and for worst symptom in secondary data analyses . Conclusion : Diquafosol tetrasodium was well tolerated and was superior to placebo ( vehicle ) in reducing corneal staining and in relieving certain patient symptoms . Diquafosol has a favorable risk/benefit profile in a broad spectrum of patients with dry eye disease and is a novel topical treatment of dry eye PURPOSE To compare the therapeutic effect between autologous serum and umbilical cord serum eye drops in the treatment of severe dry eye syndrome . DESIGN Prospect i ve case-control study . METHODS Ninety-two eyes of 48 patients with severe dry eye syndrome ( 34 eyes of 17 patients with Sjögren syndrome and 58 eyes of 31 patients with non-Sjögren syndrome ) were treated with either 20 % autologous serum ( 41 eyes of 21 patients ) or umbilical cord serum eye drops ( 51 eyes of 27 patients ) . Symptom scoring , corneal sensitivity test , tear film break-up time ( BUT ) , Schirmer test , tear clearance rate ( TCR ) , corneal fluorescein staining , and conjunctival impression cytologic analysis were performed before and one month and two months after treatment . RESULTS Both autologous serum and umbilical serum treatments led to improvement in the symptom score , tear film BUT , keratoepitheliopathy score , and impression cytologic findings . Symptom and keratoepitheliopathy scores were lower at one month ( P = .03 and P = .12 ) and two months ( P = .04 and .02 ) for those treated with umbilical cord serum compared with those treated with autologous serum . In Sjögren syndrome patients , goblet cell density was higher at two months of umbilical cord serum treatment compared with autologous serum treatment ( P = .04 ) . CONCLUSIONS Umbilical cord serum eye drops were more effective in decreasing symptoms and keratoepitheliopathy in severe dry eye syndrome and increasing goblet cell density in Sjögren syndrome compared with autologous serum eye drops Purpose : To set priorities for new systematic review s ( SRs ) and r and omized clinical trials on the management of primary angle closure ( PAC ) using clinical practice guidelines and a survey of Asia-Pacific clinicians . Methods : We restated the American Academy of Ophthalmology ’s Preferred Practice Patterns recommendations for management of PAC into answerable clinical questions . We asked participants at the Asia-Pacific Joint Glaucoma Congress 2010 in Taipei to rate the importance of having an answer to each question for providing effective patient care , using a Likert-type scale and scoring from 0 ( not important at all ) to 10 ( highly important ) . We identified relevant SRs and mapped the evidence to clinical questions to identify evidence gaps . Results : We generated 42 clinical questions . One hundred seventy-five individuals agreed to participate in the survey , 132 responded ( 75.4 % response rate ) and 96 completed the question naire ( 54.9 % usable response rate ) . Questions rated important include laser iridotomy for the prevention of angle closure in primary angle-closure suspects , further therapies in eyes with plateau iris syndrome after laser iridotomy , and evaluation of the fellow eye in acute angle-closure patients for improving prognosis . Up-to- date and conclusive SR evidence was not available for any of the 42 clinical questions . Conclusions : We identified high priority clinical questions on the management of PAC , none of which had reliable SR evidence available . New SRs and r and omized clinical trials can be initiated to address these evidence gaps PURPOSE Sjögren 's syndrome ( SS ) is a systemic autoimmune disease characterized by salivary and lacrimal gl and ular destruction leading to symptoms of dry mouth and dry eye . Dryness can also occur in the absence of gl and ular destruction . Patients with SS have autoantibodies that bind to muscarinic acetylcholine receptors in the exocrine gl and s. Recently , a muscarinic acetylcholine receptor agonist , cevimeline , has been approved for use against symptoms of dry mouth in patients with SS . In this study , the efficacy of cevimeline in improving symptoms of dry eye was examined . DESIGN Prospect i ve , r and omized , double-blind , multi-center clinical study . METHODS Sixty patients were r and omly assigned to three groups-placebo ; cevimeline , 20 mg three times daily ; or cevimeline , 30 mg three times daily- and received treatment for 4 weeks . Patients were evaluated before treatment , at week 2 , at the end of treatment , and at the end of a 2- to 4-week follow-up period . RESULTS Compared with the placebo , statistically significant differences were seen with cevimeline , 20 mg three times daily , in subjective symptoms , tear dynamics , condition of the corneoconjunctival epithelium , and global improvement rating . No difference was found among the three groups regarding the safe use of the drug . CONCLUSIONS These results indicate that cevimeline , 20 mg three times daily , is safe and effective in improving symptoms of dry eye in patients with SS . Additional studies , with larger patient population s , are needed to further assess the effectiveness of cevimeline for dry eye Purpose . This r and omized , double-masked study compared the effectiveness of two commercially available ocular lubricants containing either 0.3 % Carbomer 934 or 0.18 % sodium hyaluronate ( SH ) in treating moderate dry eye . Methods . Sixty-five subjects with dry eye were recruited and supplied with eyedrops containing either Carbomer or SH to use for a month . Principle outcome measures were the severity of symptoms of ocular irritation , tear break-up time without ( NIBUT ) and with ( TBUT ) fluorescein , and corneal and conjunctival staining with fluorescein and lissamine green , respectively . At the end of the experiment , subjects were also asked , on average , how many times a day they used the treatment and the duration of any postinstillation blur . Results . Both Carbomer and SH reduced the symptom severity and ocular surface staining , but neither had a lasting effect on NIBUT or TBUT . The treatment effects of Carbomer and SH were equivalent for symptoms , NIBUT and TBUT . However , for both corneal and conjunctival staining , SH outperformed Carbomer in improving the integrity of the ocular surface . There was no difference in the average instillation frequency of the two products . Visual disturbance after instillation of either formulation was generally short , but lengthy periods of blur were significantly more common after the use of Carbomer . Conclusions . Both of the eyedrops trialled are suitable for patients with moderate dry eye , but of the two , the SH-containing treatment has marginal benefits in therapeutic efficacy and has less propensity to cause visual disturbance Objective : Dehydroepi and rosterone ( DHEA ) administration has been reported to improve fatigue , psychological distress , and physical disability . These are common features of primary Sjögren syndrome ( pSS ) . We investigated the effects of DHEA administration on fatigue , well-being , and functioning in women with pSS . Methods : In a double-blind , r and omised placebo-controlled clinical trial , 60 female patients with pSS received 200 mg oral DHEA or placebo . Primary outcome measures were general fatigue , depressive mood , mental well-being , and physical functioning . In addition , pain , sicca complaints and disease activity parameters were measured . Patients were assessed before treatment , after 3 , 6 , and 12 months on study medication , and 6 months after cessation of treatment . Results : Patients from both the DHEA- and placebo-treated group improved on general fatigue ( p<0.001 ) , mental well-being ( p = 0.04 ) , and depressive mood ( p = 0.008 ) . Physical functioning did not change ( p = 0.44 ) . Of the secondary outcome variables , complaints of a dry mouth diminished during treatment in both groups ( p = 0.006 ) , the erythrocyte sedimentation rate showed a decrease for the DHEA group ( p = 0.02 ) , and complaints of dry eyes improved in the placebo group ( p = 0.01 ) . The belief to have used DHEA was a stronger predictor for improvement of fatigue and well-being than the actual use of DHEA . Conclusions : Our study does not support a superior effect of DHEA over placebo in female patients with pSS . Both DHEA and placebo induce improvement of fatigue and well-being . This may suggest possibilities for cognitive behavioural interventions Cevimeline hydrochloride , a specific agonist of the M3 muscarinic receptor , is beneficial in the treatment of symptoms of xerostomia and xerophthalmia associated with Sjögren ’s syndrome ( SS ) .  Cevimeline has not been evaluated in southern Chinese patients . Furthermore , the effects of cevimeline on health-related quality of life and oral health status are not known . In this r and omised , double-blind , placebo-controlled crossover study , patients received cevimeline 30 mg or matched placebo three times per day over 10 weeks followed by a 4-week washout period before treatment crossover . Participants self-completed the following question naires : Xerostomia Inventory ( XI ) , the General Oral Health Assessment Index ( GOHAI ) , the Ocular Surface Disease Index ( OSDI ) and the Medical Outcomes Short Form ( SF-36 ) . Clinical assessment s included sialometry , examination of the oral cavity for the degree of xerostomia and dental complications of xerostomia .  Fifty patients ( 22 primary SS and 28 secondary SS ) were enrolled in the trial . Forty-four patients completed the study . There was a significant improvement in the XI and GOHAI scores as well as the objective rating of xerostomic signs of the oral cavity after treatment with cevimeline . However , there was no improvement in salivary flow rates and dry eye symptoms . SS patients had lower SF-36 scores , but these did not improve after treatment with cevimeline Purpose To determine the beneficial effect of topically administered Cyclosporine A ( CsA ) for the dry eye findings of thyroid orbitopathy patients . Patients and methods This prospect i ve pilot study included 73 eyes of 42 patients with thyroid orbitopathy who had documented dry eye findings . Patients were r and omly assigned into two groups : in group 1 ( 48 eyes ) , patients received topical artificial tear-drop treatment . In group 2 ( 25 eyes ) , patients received topical CsA and artificial tear-drop treatment . During a mean follow-up of 6 months , change in Schirmer 's test with aneasthesia , tear break-up-time ( BUT ) and impression cytology results were analyzed and were compared between groups . Results The two groups were age ( P=0.449 ) and gender ( P=0.942 ) matched . The Schirmer 's test ( P=0.441 ) , tear BUT ( P=0.718 ) and impression score ( P=0.103 ) were also similar before the treatment in both groups . In group 1 , all three parameters improved significantly with treatment ( P<0.001 for all ) . In group 2 , Schirmer 's test ( P=0.001 ) and tear BUT ( P<0.001 ) improved , but the impression score ( P=0.175 ) did not change significantly after treatment . The percentage of patients with improved tear BUT ( P=0.04 ) and improved impression score ( P<0.001 ) were higher in group 1 . At the end of follow-up , group 1 patients had better Schirmer 's test ( P=0.004 ) , tear BUT ( P=0.021 ) and impression scores ( P<0.001 ) , than group 2 patients . Conclusions The combined CsA use with artificial tear drops is not more advantageous than the use of artificial tear drops alone , for the dry eye findings of thyroid orbitopathy patients AIM To evaluate the role of dietary supplementation of omega-3 fatty acids in dry eye syndrome . METHODS A prospect i ve , interventional , placebo controlled , double blind r and omized trial was done at two referral eye centers . Two hundred and sixty-four eyes of patients with dry eye were r and omized to receive one capsule ( 500 mg ) two times a day containing 325 mg EPA and 175 mg DHA for 3 months ( omega-3 group ) . The omega-3 group was compared to a group of patients ( n=254 ) who received a placebo ( placebo group ) . There were 4 patient visits ( at baseline , 1 month , 2 months and 3 months ) . On each visit , recording of corrected distance visual acuity ( CDVA ) , slit lamp examination and question naire based symptom evaluation and scoring was done . A symptomatic score of 0 - 6 was mild , 6.1 - 12 moderate and 12.1 - 18 severe dry eye . Response to intervention was monitored by routine tear function tests like Schirmer I test , tear film break-up time ( TBUT ) , Rose Bengal staining and most notably , conjunctival impression cytology . RESULTS Sixty-five percent of patients in the omega-3 group and 33 % of patients in placebo group had significant improvement in symptoms at 3 months ( P=0.005 ) . There was a significant change in both Schirmer 's test value and TBUT values in the omega-3 group ( P<0.001 ) , both comparisons . However , there was a larger drift in TBUT values in omega-3 than the placebo group , in comparison to Schirmer 's test values . The mean TBUT score was 2.54±2.34 in the omega-3 group and 0.13±0.16 in placebo group , respectively . The mean reduction in symptom score in omega-3 group was 2.02±0.96 as compared to 0.48±0.22 in placebo group ( P<0.001 ) . Despite a slight increase mean score , the Schirmer scores did not correlate well with symptomatic improvement . CONCLUSION Omega-3 fatty acids have a definite role for dry eye syndrome . The benefit seems to be more marked in conditions such as blepharitis and meibomian gl and disease . The role of omega fatty acids in tear production and secretion needs further evaluation PURPOSE With the potential to address evaporative dry eye , a novel spray has been developed in which phospholipid liposomes are delivered to the tear film via the surface of the closed eyelid . This study evaluated the short-term effects of liposomal spray application on the lipid and stability characteristics of the pre-ocular tear film in normal eyes . METHODS Twenty-two subjects ( 12 M , 10F ) aged 35.1+/-7.1 years participated in this prospect i ve , r and omised , double-masked investigation in which the liposomal spray was applied to one eye , and an equal volume of saline spray ( control ) applied to the contralateral eye .  Lipid layer grade ( LLG ) , non-invasive tear film stability ( NIBUT ) and tear meniscus height ( TMH ) were evaluated at baseline , and at 30 , 60 , 90 and 135min post-application . Subjective reports of comfort were also compared . RESULTS Treated and control eyes were not significantly different at baseline ( p>0.05 ) . Post-application , LLG increased significantly , at 30 and 60min , only in the treated eyes ( p=0.005 ) . NIBUT also increased significantly in the treated eyes only ( p<0.001 ) , at 30 , 60 and 90min . TMH did not alter significantly ( p>0.05 ) . Comfort improved relative to baseline in 46 % of treated and 18 % of control eyes , at 30min post-application . Of those expressing a preference in comfort between the eyes , 68 % preferred the liposomal spray . CONCLUSIONS Consistent with subjective reports of improved comfort , statistically and clinical ly significant improvements in lipid layer thickness and tear film stability are observed in normal eyes for > or = 1h after a single application of a phospholipid liposomal spray Aim and purpose To evaluate the effects of two NSAIDs on corneal sensitivity and ocular surface in Sjögren 's syndrome ( SS ) patients . Methods In all , 20 SS patients with epithelial corneal defects , were r and omly divided into two groups : group 1 ( 10 females , age 35–63 years ) , treated with 0.1 % indomethacin , one drop three times a day ; group 2 ( nine females , one male , age 38–65 years ) treated with 0.1 % diclofenac , at the same regimen . No systemic NSAIDs were allowed . Use of tear substitute was allowed . Corneal sensitivity , corneal staining , BUT , and ocular discomfort , were evaluated before and after 15 , 30 days of treatment and 7 days after NSAID discontinuation . For statistical analysis , the Student 's t-test and Mann – Whitney U test were used . Results Both groups showed at day 30 a statistically significant reduction of corneal sensitivity ( P<0.05 ) , although the diclofenac-treated group showed a statistically significant lower sensitivity if compared to the indomethacin-treated group ( P<0.05 ) . Corneal fluorescein score showed a statistically significantly worst alteration in group 2 , 7 days after the discontinuation of the therapy ( P=0.02 ) . The ocular discomfort score was statistically significantly reduced in both groups starting from day 15 ( P<0.05 ) . Discussion The results indicate that NSAIDs can be useful in resolving symptoms of ocular discomfort in SS patients . However , they should be used with caution and under close monitoring , and the treatment should be promptly discontinued if corneal epithelial defects develop or worsen during treatment Objective : To investigate the efficacy of topical cyclosporine A 0.05 % ( tCsA ) ( Restasis ® , Allergan Pharmaceuticals ) in the treatment of meibomian gl and dysfunction ( posterior blepharitis ) . Methods : Thirty-three patients with symptomatic meibomian gl and dysfunction were r and omized in a prospect i ve study to either tCsA or placebo ( Refresh Plus ® preservative-free artificial tears ) , 2 times daily for 3 months . They were evaluated at baseline and at 1 , 2 , and 3 months for subjective symptoms and objective signs including meibomian gl and inclusion s , lid margin vascular injection , tarsal telangiectasis , fluorescein staining , tear breakup time , and Schirmer scores . Results : Twenty-six patients completed the study . All patients were tested for ocular symptoms , lid margin vascularity , tarsal telangiectasis , meibomian gl and inclusion s , tear breakup time , and fluorescein staining . At the 3-month visit , the tCsA group showed a greater improvement in ocular symptoms than the placebo group , but this difference was not statistically significant . At the 3-month visit , several objective examination findings were statistically significantly ( P < 0.05 ) improved in the tCsA group compared with the placebo group . These differences included lid margin vascular injection , tarsal telangiectasis , and fluorescein staining . The most significant finding ( P = 0.001 ) was the greater decrease in the number of meibomian gl and inclusion s in the tCsA group compared with the placebo group . Conclusions : Topical CsA may be helpful in the treatment of meibomian gl and dysfunction ( posterior blepharitis ) . Topical CsA did not induce an improvement in the symptoms , but it did decrease the number of meibomian gl and inclusion s in patients with meibomian gl and dysfunction Purpose To assess the additive effect of diquafosol tetrasodium on sodium hyaluronate monotherapy in patients with dry eye syndrome . Methods This study evaluated 64 eyes of 32 patients ( age : 62.6±12.8 years ( mean±SD ) ) in whom treatment with 0.1 % sodium hyaluronate was insufficiently responsive . The eyes were r and omly assigned to one of the two regimens in each patient : topical administration of sodium hyaluronate and diquafosol tetrasodium in one eye , and that of sodium hyaluronate in the other . Before treatment , and 2 and 4 weeks after treatment , we determined tear volume , tear film break-up time ( BUT ) , fluorescein and rose bengal vital staining scores , subjective symptoms , and adverse events . Results We found a significant improvement in BUT ( P=0.049 , Dunnett test ) , fluorescein and rose bengal staining scores ( P=0.02 ) , and in subjective symptoms ( P=0.004 for dry eye sensation , P=0.02 for pain , and P=0.02 for foreign body sensation ) 4 weeks after treatment in the diquafosol eyes . On the other h and , we found no significant change in these parameters after treatment in the control eyes . Conclusions In dry eyes , where sodium hyaluronate monotherapy was insufficient , diquafosol tetrasodium was effective in improving objective and subjective symptoms , suggesting its viability as an option for the additive treatment of such eyes BACKGROUND Retroviral infection has been implicated in the pathogenesis of primary Sjögren 's syndrome . OBJECTIVE To examine the efficacy of the reverse transcriptase inhibitor lamivudine in patients with this syndrome . METHODS 16 patients with primary Sjögren 's syndrome were r and omised to receive either lamivudine 150 mg twice daily or placebo for three months . Measures of lacrimal and salivary function , including minor salivary gl and biopsies , were obtained before and after treatment . RESULTS Treatment with lamivudine did not result in significant improvement in the primary outcome measure of unstimulated whole salivary flow or other secondary measures , including minor salivary gl and biopsy focus scores . CONCLUSION Lamivudine is not effective in patients with primary Sjögren 's syndrome , suggesting either that a retroviral aetiology is not present or that it may be important only in early disease BACKGROUND Evaporative dry eye is the most common form of tear film dysfunction . The present trial aims to evaluate the efficacy of two established treatment options with different modes of action by comparison . PATIENTS / MATERIAL AND METHODS 216 patients suffering from evaporative dry eye were included in this prospect i ve , r and omised two-centre trial . Divided into two treatment groups , patients either received treatment with hyaluronate artificial tears ( Vismed light ) or a phospholipid-liposome eye spray ( Tears Again ) , each for three months . Tests ( lid-parallel conjunctival folds [ LIPCOF ] , non-invasive break-up time [ NIBUT ] , Schirmer 's test , inspection of lids and subjective assessment ) were performed before as well as 4 and 12 weeks after initiation of this study . RESULTS In the patients of the eye spray group there was a significantly greater reduction of the LIPCOF grade ( p < 0.02 ) and the grade of inflammation of the lid margin ( p < 0.002 ) . With respect to the tear film break-up time ( NIBUT ) there was a significant difference between the results of both groups ( p < 0.003 ) . The improvement of the break-up time in patients of the eye spray group turned out to be more than twice as high as that in the artificial tears group . CONCLUSIONS Both therapies improved evaporative dry eye , but patients on phospholipid-liposomal eye spray demonstrated greater clinical benefit from their therapy , particularly regarding the degree of inflammation of the lid margins as well as the grade of LIPCOF . When compared to hyaluronate artificial tears , NIBUT more than doubled in the phospholipid-liposome eye spray group . Clinical severity of dry eye is more pronounced when evaporative dry eye and aqueous tear deficiency coincide . A combination of the phospholipid-liposome eye spray and artificial tears appears to represent a considerable advancement in tear replacement therapy for severe cases of dry eye Purpose : To determine the effect of an oil-in-water emulsion eye drop compared with a conventional dry eye supplement ( hypromellose ) on tear physiology in dry eye . Methods : A r and omized parallel , longitudinal , and investigator-masked study of the efficacy of 1.25 % castor oil emulsion and 0.32 % hypromellose solution was carried out . A total of 53 patients with mild to moderate dry eye ( 27 in emulsion group and 26 in hypromellose group ) were recruited for the study . Patients were enrolled if they reported at least 2 symptoms on a McMonnies Dry Eye Question naire together with 1 of the following screening tests : noninvasive tear breakup time ( 5 - 10 seconds ) and Schirmer test without anesthesia ( 2 - 5 mm in 5 minutes ) . Patients were instructed to use the test solutions 3 times a day for 30 days . Tear production , evaporation , lipid layer structure , and osmolality were measured before and 30 days after use of the drops . Results : A statistically significant decrease was seen after 1 month in tear evaporation rates with both emulsion ( 7.25 ± 5.43 g/m2/h ) and hypromellose ( 2.02 ± 4.75 g/m2/h ) . However , the decrease with emulsion was significantly greater than with hypromellose ( P < 0.001 ) . Lipid layer structure improved from day 1 to day 30 of the study with the emulsion but not with the hypermellose . No significant changes were seen in tear production and osmolality with either of the drops . Conclusions : The oil-water emulsion was more effective in reducing tear evaporation than hypromellose after repeated application over a 1-month period . This finding signifies the potential of the emulsion in the management of evaporative dry eye PURPOSE Symptoms of dry eye are commonly reported in contact lens wearers and are a frequent cause of non-tolerance . The purpose of the present study is to evaluate the effects of oral treatment with particular omega-6 fatty acids in the form of evening primrose oil ( EPO ) on subjective symptoms , ocular surface signs and tear film characteristic in patients with contact lens associated dry eye . METHODS The study design was r and omised , double-masked and placebo controlled . 76 female soft contact lens wearers were treated for 6 months with either EPO or placebo ( olive oil ) . Subjects underwent three examinations ( baseline , 3 and 6 months ) . At each examination subjects were given a question naire relating to lens comfort and dry eye symptoms and underwent a series of tests of tear film characteristics ( tear meniscus height , break-up time ) , meibomian gl and function ( lipid layer thickness and quality ) and ocular surface parameters ( hyperaemia and staining ) . RESULTS The EPO group showed a significant improvement in the specific symptom of ' dryness ' at 3 and 6 months ( p<0.01 ) and also a significant improvement in overall lens comfort at 6 months ( p<0.01 ) . Tear meniscus height was increased in the EPO group at 6 months relative to baseline ( p<0.01 ) , although all other objective signs were unchanged . CONCLUSION This study provides evidence for a beneficial effect of particular orally administered omega-6 fatty acids in alleviating dry eye symptoms and improving overall lens comfort in patients suffering from contact lens associated dry eye Purpose : The aim of this study was to evaluate the treatment effect of diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % eye drops in dry eye syndrome . Methods : In total , 150 patients with dry eye syndrome were divided r and omly into 3 groups . Group 1 ( 50 patients ) was treated 4 times daily with preserved sodium hyaluronate 0.1 % , group 2 ( 50 patients ) was treated 4 times daily with diquafosol 3 % , and group 3 ( 50 patients ) was treated 4 times daily with diquafosol 3 % and preservative-free sodium hyaluronate 0.1 % eye drops for 3 months . Ocular surface disease index ( OSDI ) score , tear film break-up time , Schirmer I test , corneal fluorescein staining , and impression cytology were evaluated . Results : There were significant improvements in the OSDI score , tear film break-up time , Schirmer I score , fluorescein and Rose Bengal staining , goblet cell density , and impression cytological findings in groups 2 and 3 compared with those for group 1 in patients with dry eye syndrome at 1 , 2 , and 3 months ( P < 0.05 ) . There were statistically significant improvements in the OSDI score ( −8.48 ± 0.97 , −5.69 ± 0.78 ; P = 0.02 ) , fluorescein ( −1.43 ± 0.21 , −1.02 ± 0.18 ; P = 0.03 ) , and Rose Bengal staining ( −1.12 ± 0.26 , −0.75 ± 0.12 ; P = 0.03 ) , goblet cell density ( 89.65 ± 14.39 , 70.36 ± 16.75 ; P = 0.03 ) , and impression cytological findings ( −0.53 ± 0.12 , −0.34 ± 0.90 ; P = 0.01 ) in group 3 compared with those in group 2 at 3 months . Conclusions : Treatment with diquafosol 3 % with preservative-free sodium hyaluronate 0.1 % was more effective than diquafosol 3 % monotherapy or treatment with preserved sodium hyaluronate 0.1 % in dry eye syndrome . Preservative-free sodium hyaluronate 0.1 % eye drops can increase the effect of diquafosol 3 % in dry eye syndrome Background Sodium hyaluronate ( SH ) is used in patients with dry eye . We evaluated the efficacy and safety of SH and carboxymethylcellulose ( CMC ) in the treatment of dry eye syndrome with superficial keratitis . Methods A total of 22 patients with moderate dry eye and superficial keratitis were enrolled in a prospect i ve , r and omised , masked-observer , parallel-group , single-centre study . Patients were r and omly assigned to a 0.18 % SH or 1 % CMC solution for a 2-month period . In addition to the commonly assessed parameters in patients with dry eye ( among others symptoms and corneal staining with fluorescein ) , flow cytometry analysis of CD44 , HLA DR expressions in impression cytology was investigated as a potential efficacy parameter . Results Both treatments improved the symptoms and ocular surface and were well tolerated .  SH significantly ( p<0.05 ) decreased CD44 values compared with  CMC .  Comfort was significantly ( P<0.05 ) better in the SH group than that in the CMC group throughout the study . Recovery in keratitis ( type , extent and depth ) and symptoms were faster in the SH group than in the CMC group . Blurred vision was reported by patients in the CMC group only . Conclusions SH was well tolerated and tended to show a faster efficacy than did the CMC-based formulation in patients with moderate dry eye and superficial keratitis . SH could therefore advantageously be prescribed from the early stages of dry eye disease . This study also showed that flow cytometry in impression cytology specimens is a reliable tool for exploring the ocular surface at the epithelial level and that CD44 , in addition to HLA DR , could be an interesting endpoint for future trials in dry eye syndrome with products based on SH PURPOSE To evaluate the efficacy of three commercially available lubricant eye drops for the treatment of mild , dry , irritated eyes . METHODS R and omized , investigator-masked evaluation of 60 patients in which 20 patients used  carboxymethylcellulose sodium ( CMC ) , 0.5 % ( Cellufresh ) , Allergan Inc. , Irvine , CA ) ( group 1 ) ; 20 patients used a drop containing polyethylene glycol 400 , 2.5 % and sodium hyaluronate ( Blink Intensive Tears , Abbott Medical Optics Inc. , Santa Ana , CA ) ( group 2 ) ; and 20 patients used  HP Guar 0.18 % ( Systane , Alcon Laboratories Inc. , Ft . Worth , TX ) ( group 3 ) . Study visits were at baseline and 1 month . Tests performed at both visits included Schirmer , tear-film break-up time ( TBUT ) , visual acuity , fluorescein staining , tear osmolarity and wavefront aberrometry . Osmolarity testing was performed prior to instillation of the lubricant eye drops and then a final time 5min after instillation of the drop at both day 1 and day 30 . Tear osmolarity was performed only in the right eye and only one time before and after instillation of lubricant eye drops . RESULTS At day 1 the mean reduction in osmolarity 5min after instillation of the lubricant eye drop was , -5.0+/-1.9 in group 1 , -9.0+/-4.2 in group 2 and -5.0+/-2.2 in group 3 . At day 30 the mean reduction in osmolarity 5min after instillation of the lubricant eye drop was , -5.6+/-2.3mOsm/L in group 1 ; -9.9+/-2.8mOsm/L in group 2 and -4.5+/-1.8mOsm/L in group 3 . The differences were statistically significant between groups 1 and 2 , and 2 and 3 . There was a reduction of osmolarity from day 1 to day 30 but the differences were not statistically significant . We feel that after a 30-day treatment with the lubricant eye drops , the lower osmolarity values could indicate that the tear film is progressing towards a more normal osmolarity value . A future study could examine the tear osmolarity value after 60 or 90 days of usage . LogMAR best-corrected visual acuity ( BCVA ) results showed an improvement in group 2 compared with baseline with no change in BCVA in groups 1 and 3 . There was no statistically significant change from day 1 to 1 month in TBUT , while the Schirmer test showed an improvement in all groups at 1 month . CONCLUSIONS Assessment of tear osmolarity provides the most objective , measurable test for determining improvement in dry eye patients . The instillation of any artificial tear or lubricant eye drop should decrease the tear-film osmolarity . The results found that polyethylene glycol 400 , 0.25 % and sodium hyaluronate ( Blink Intensive Tears ) significantly improved tear osmolarity compared with carboxymethylcellulose sodium ( CMC ) , 0.5 % ( Cellufresh ) and HP Guar 0.18 % ( Systane after instillation PURPOSE To compare the efficacy of vitamin A ( retinyl palmitate ) and cyclosporine A 0.05 % eye drops in treating patients with dry eye disease . DESIGN Prospect i ve , r and omized , controlled , parallel group study . METHODS A total of 150 patients with defined dry eye disease participated ( 50 in each treatment group ) . In 3 identical clinical trials , patients were treated twice daily with cyclosporine A 0.05 % , or four times daily with retinyl palmitate 0.05 % , or with neither cyclosporine or retinyl palmitate . Adjunctive treatment with preservative-free artificial tears was undertaken four times daily in all 3 groups . Corneal fluorescein staining results , Schirmer tear test ( without anesthesia ) results , tear film break-up time ( BUT ) , dry eye symptom score , and impression cytologic analysis results were obtained before treatment and at the first , second , and third months after initiation of treatment . RESULTS Both vitamin A eye drops and topical cyclosporine A 0.05 % treatments led to significant improvement in blurred vision , tear film BUT , Schirmer I score results , and impression cytologic findings in patients with dry eye syndrome ( P < .05 ) compared to the control group treated with preservative-free artificial tears alone . CONCLUSIONS Both vitamin A eye drops and topical cyclosporine A 0.05 % treatments are effective for the treatment of dry eye disorder CONTEXT Serum levels of the sex steroid prohormones dehydroepi and rosterone ( DHEA ) and DHEA sulfate ( DHEA-S ) decline upon aging and are reduced in primary Sjogren 's syndrome . OBJECTIVE Our aim was to investigate : 1 ) effects of 50 mg oral DHEA/day on changes in serum levels of DHEA and 12 of its metabolites ; 2 ) relationships between steroid levels and disease characteristics ; and 3 ) whether these parameters were influenced by DHEA . DESIGN Twenty-three postmenopausal women with primary Sjogren 's syndrome and subnormal levels of DHEA-S were included in a r and omized , 9-month , controlled , double blind crossover study . Liquid chromatography/mass spectrometry (MS)/MS and gas chromatography/MS were used to measure the sex steroids . Anti-SS-A/Ro and /or anti-SS-B/La , salivary gl and focus score , salivary flow rates , dry mouth and eye symptoms , and routine laboratory tests were assessed . RESULTS Baseline erythrocyte sedimentation rate was inversely correlated with testosterone ( Testo ) , dihydrotestosterone , and DHEA-S ( rs = -0.42 , -0.45 , and -0.58 , respectively ) . Dry mouth symptoms correlated with low Testo and and rostenedione , whereas dry eyes correlated with low estrogens , most strongly estrone ( rs = -0.63 ) . Presence of anti-SS-A and /or anti-SS-B was independently associated with low estradiol ( area under the receiver operating characteristic curve , 0.82 ) . All metabolites increased during DHEA but not during placebo . The relative increases were less for estrogens and Testo compared to dihydrotestosterone and glucuroni date d and rogen metabolites . Dry mouth symptoms decreased during DHEA therapy . CONCLUSIONS Disease manifestations in primary Sjogren 's syndrome were associated with low sex hormone levels , dry mouth symptoms with low and rogens , and dry eyes with low estrogens . Exogenous DHEA was preferentially transformed into and rogens rather than into estrogens INTRODUCTION Polyunsaturated fatty acids ( PUFAs ) are involved in inflammatory pathways via prostagl and ins . Conjunctival inflammation is a hallmark of all dry eye syndromes . We investigated the role of dietary n-6 and n-3 fatty acids in patients suffering from ocular dryness . PATIENTS AND METHODS Seventy-one patients presenting with mild to moderate dry eye syndromes were r and omly assigned to Nutrilarm or placebo capsules , twice a day for 6 months . The Schirmer test , BUT , fluorescein staining , and lissamin green stainings were performed at inclusion and after 1 , 3 , and 6 months . Furthermore , a question naire related to the dry eye symptoms and global discomfort was provided at every visit . RESULTS The Schirmer test , BUT , fluorescein staining , and lissamin green stainings were improved with treatment when compared to placebo but the difference was not statistically significant . The efficacy evaluated by the patients and the investigator were nearly significant ( p=0.052 and p=0.054 , respectively ) . For some signs , such as reflex tearing and conjunctival hyperemia , the improvement reached the threshold of significance ( p=0.047 and p=0.045 , respectively ) . The same results were found with skin quality and emotional condition , which were improved ( 61 % with treatment versus 36 % with placebo ) . CONCLUSION This double-masked pilot study shows that PUFAs seem to be an interesting tool to alleviate the symptoms related to dry eye syndrome . These results should be confirmed using a larger study population PURPOSE To evaluate the effectiveness of the autologous serum eyedrops in the treatment of severe dry eye patients . DESIGN Prospect i ve r and omized case-control study . METHODS Thirty-seven eyes of twenty severe dry eye patients without punctal occlusion were enrolled in this study . After 2 weeks of washout , they were r and omly assigned to two groups . Group A patients used only preservative-free artificial tears , and group S patients used only autologous serum eyedrops . We evaluated the results of Schirmer test , fluorescein and rose bengal staining scores , tear film breakup time ( BUT ) , and subjective symptom scores before and 2 weeks after treatment . RESULTS Mean BUT and fluorescein and rose bengal staining scores , as well as subjective symptom scores , showed significant improvement in the patients assigned to autologous serum eyedrops compared with subjects assigned to preservative-free artificial tears after 2 weeks of treatment . CONCLUSIONS Autologous serum eyedrops were found effective in the treatment of severe dry eye disease , as evidence d by improvement of tear stability and ocular surface vital staining scores Objectives : The aim was to compare the effects of topical cyclosporine A and artificial tears combination with artificial tears alone in patients with dysfunctional tear syndrome ( DTS ) . Methods : Forty-two eyes of 42 patients with DTS were enrolled in the study . The inclusion criteria for the study were Schirmer I ( without anesthesia ) scores below 10 mm/5 min and tear film break-up time ( BUT ) below 10 sec. The patients were r and omly divided into two groups . The study group ( 22 patients ) underwent 0.05 % cyclosporine A treatment twice a day and preservative-free artificial tears for four times a day for 4 months . The control group ( 20 patients ) was administered only preservative-free artificial tears four times a day for 4 months . The BUT , Schirmer test scores , corneal fluorescein staining , conjunctival lissamine green staining , and goblet cell density derived by impression cytology were recorded before and after treatment in each group . Results : In the study group , all parameters improved statistically significantly after treatment at the 4-month follow-up compared with the pretreatment values ( P<0.001 for all ) . In the control group , corneal fluorescein staining ( P<0.001 ) and conjunctival lissamine green staining ( P=0.014 ) improved , but BUT and Schirmer scores did not change significantly after treatment . At the end of the 4-month follow-up , the study group demonstrated statistically significantly better BUT ( P=0.020 ) , Schirmer scores ( P=0.002 ) , goblet cell density ( P=0.006 ) , corneal fluorescein staining ( P=0.003 ) , and conjunctival lissamine green staining ( P=0.017 ) scores than did the control group . Conclusions : Topical cyclosporine A and artificial tears treatment significantly increases goblet cell density , decreases the signs of DTS , and improves ocular surface health Purpose . To evaluate the efficacy of marketed artificial tears in relieving the signs and symptoms of dry eye  when used as supportive therapy to a cyclosporine-based ophthalmic emulsion . Methods . Sixty-one patients were enrolled in this r and omized , investigator-masked , parallel study of 6 months ' duration . Eligible patients needed a Schirmer I score without anesthesia of 7 mm or less at day –7 and to answer that they needed artificial tears at least “ some of the time . ” Corneal staining of 3 or more ( National Eye Institute grid , 15 points ) at day –7 and day 0 in the same eye was also required . Patients were r and omized to one of three regimens : Restasis ( 0.05 % cyclosporine ) twice per day with Systane used a minimum of once per day ( Restasis + Systane ) ; Restasis twice per day with Refresh Tears used a minimum of once per day ( Restasis + Refresh ) ; and Systane alone used four times per day . Signs and symptoms were measured at days –7 , 0 , 7 , 14 , 28 , 42 , 120 , and 180 . Results . A statistical difference was seen in favor of Restasis + Systane versus Restasis + Refresh for corneal staining ( P=0.0048 ) change from baseline and a trend ( P=0.0725 ) for increased tear film breakup time at 6 months . There were no differences between treatment groups for Schirmer score , conjunctival staining , or conjunctival injection . Significant differences were seen in favor of Restasis + Systane versus Restasis + Refresh for less ocular burning ( P=0.0210 ) , stinging ( P=0.0314 ) , grittiness ( P=0.0128 ) , and dryness ( P=0.0132 ) . Systane was better than Restasis + Refresh for less burning ( P=0.0288 ) , dryness ( P=0.0480 ) , and scratchiness ( P=0.0294 ) . Conclusions . Results indicate that the choice of concomitant therapy used with Restasis has significant effects on outcome measures . Both supportive therapies were compatible with Restasis PURPOSE To assess the reversibility of clinical benefits of cyclosporine 0.05 % ( Restasis ( ® ) ; Allergan , Inc. , Irvine , CA ) therapy and the therapeutic gain after its delayed use by switching treatment modalities in patients with dry eyes who completed a 1-year course of therapy with artificial tears ( Refresh Endura ( ® ) ; Allergan , Inc. , Irvine , CA ) or cyclosporine 0.05  % . METHODS This was a single-center , prospect i ve , investigator-masked , longitudinal extension trial . Patients who had been treated with cyclosporine 0.05 % in the first year of study were r and omized in a 2:1 ratio to either cyclosporine 0.05 % ( Cs-Cs ; n=20 ) or artificial tears ( Cs-At ; n=8 ) , and those who had been originally r and omized to artificial tears were switched to cyclosporine 0.05 % ( At-Cs ; n=20 ) in the second year of study . Patients received study drugs twice daily for 12 months . Disease severity was assessed according to the International Task Force consensus guideline at months 0 and 12 . Signs and symptoms were evaluated at baseline ( month 0 ) and months 4 , 8 , and 12 . RESULTS At baseline , most patients with Cs-Cs and Cs-At ( > 90 % ) had level 2 disease severity , whereas almost half of the patients with At-Cs had level 3 disease severity . At month 12 , a significantly higher percentage of patients with Cs-Cs and At-Cs than patients with Cs-At had the same or lower disease severity ( P<0.001 ) ; whereas half of patients with Cs-At , compared with patients with no Cs-Cs and At-Cs , had disease progression at month 12 . Throughout the study , dry eye signs and symptoms continuously improved in patients with Cs-Cs and At-Cs , whereas they constantly worsened in patients with Cs-At . At month 12 , patients with Cs-Cs and At-Cs had significantly greater mean percentage improvement from baseline than did patients with Cs-At in Schirmer test scores , tear breakup time , Oxford staining scores , Ocular Surface Disease Index scores , and conjunctival goblet cell density ( P<0.001 ) . Overall , sign and symptom scores of patients with At-Cs did not improve as much as they did for patients with Cs-Cs . CONCLUSIONS Cyclosporine 0.05 % withdrawal led to disease progression , thus indicating the necessity for maintenance therapy . Earlier treatment with cyclosporine 0.05 % may result in improved outcomes OBJECTIVE There is no effective treatment for patients with primary Sjögren 's syndrome ( SS ) . Since tumor necrosis factor alpha ( TNF alpha ) could be a key element in the pathogenesis of primary SS , we conducted a multicenter , r and omized , double-blind , placebo-controlled trial to evaluate the effect of infliximab in primary SS . METHODS A total of 103 patients with primary SS were r and omly assigned to receive infliximab infusions ( 5 mg/kg ) or placebo at weeks 0 , 2 , and 6 and were followed up for 22 weeks . All patients fulfilled the new American-European Consensus Group criteria for SS and had active disease as assessed by values > 50 mm on 2 of 3 visual analog scales ( VAS ) ( 0 - 100 mm ) that evaluated joint pain , fatigue , and buccal , ocular , skin , vaginal , or bronchial dryness .  A favorable overall response was defined as the patient having > or = 30 % improvement between weeks 0 and 10 in the values on 2 of the 3 VAS . Secondary end points were values on each VAS separately , the number of tender and swollen joints , the basal salivary flow rate , results of the Schirmer test for lacrimal gl and function , the focus score on labial salivary gl and biopsy , the level of C-reactive protein , and the erythrocyte sedimentation rate evaluated at weeks 0 , 10 , and 22 , as well as quality of life evaluated by use of the generic Short Form 36 question naire administered at weeks 0 , 10 , and 22 . RESULTS At week 10 , 26.5 % of patients receiving placebo and 27.8 % of patients treated with infliximab had a favorable overall response ( P = 0.89 ) , and at week 22 , 20.4 % of the placebo group and 16.7 % of the infliximab group had a favorable response ( P = 0.62 ) . In addition , the 2 groups did not differ in any of the secondary end points over the 22 weeks of the trial . Severe adverse events reported in the infliximab group did not differ from those observed in previous studies . CONCLUSION This r and omized , double-blind , placebo-controlled study of an anti-TNF agent did not show any evidence of efficacy of infliximab in primary SS Purpose : To investigate the effect of omega-3 oral nutritional supplementation on corneal reepithelialization , visual acuity , and tear stability  after photorefractive keratectomy ( PRK ) . Methods : This is a prospect i ve , r and omized , single-blinded controlled therapeutic trial using omega-3 oral nutritional supplements ( TheraTears Nutrition for Dry Eyes ; Advanced Vision Research —Akorn , Ann Arbor , MI ) conducted at our center . Eighteen healthy patients with refractive error between −1 and −8 diopters were recruited and had bilateral PRK . The treatment group ( n = 9 subjects ) received omega-3 2 weeks before surgery through 1 month after PRK . The control group ( n = 9 subjects ) was not given omega-3 . Epithelial defects were photographed on postoperative days 0 to 5 . Reepithelialization ( area in square millimeters ) was assessed by fluorescein staining until healing . Tear breakup time ( TBUT ) and uncorrected distance visual acuity were measured at 1 week , and 1 and 3 months postoperatively . Results : Epithelial defect in the treatment group eyes healed faster compared with that of the controls ( P = 0.04 ) . The treatment group eyes healed at an average rate of 1.19 % [ SD = 0.002 ; 95 % confidence interval ( CI ) , 1.04%–1.34 % ] per hour , versus 0.83 % ( SD = 0.0008 ; 95 % CI , 0.77%–0.89 % ) for controls ( Mann – Whitney rank-sum test , P < 0.001 ) . The treatment group eyes maintained a significantly longer TBUT from week 1 through 3 months ( mean = 9.52 seconds , SD = 0.81 ; 95 % CI , 8.93–10.10 ) , compared with the controls ( mean = 5.52 seconds , SD = 0.81 ; 95 % CI , 4.93–6.10 ; P < 0.001 ) , and all reached 20/20 vision versus only 4 in the control group 1 month after surgery ( P = 0.03 ) . Conclusions : Omega-3 oral nutritional supplements  decreased the average time for epithelial healing , and improved TBUT and visual acuity recovery in PRK . These findings suggested that omega-3 oral nutritional supplementation may be a beneficial adjunct therapy for PRK patients BACKGROUND / AIMS To compare the safety and efficacy of hypotonic 0.18 % sodium hyaluronate solution ( 0.18 % SH ) versus saline and versus 0.3 % carbomer for the treatment of signs and symptoms of moderate dry eye syndrome . METHODS A total of 304 patients were r and omized ( 1:1:1 ) in this parallel-group , multi-center , phase III trial . They were instructed to instill one drop of the allocated product in each eye two to four times per day over 84 days . The primary efficacy criterion was the change from baseline at Day 28 in symptom frequency score . The superiority of 0.18 % SH ( Vismed ( ® ) ) over saline and its non-inferiority versus carbomer were statistically tested . RESULTS At Day 28 , there was a statistically significant superiority of 0.18 % SH over saline in change from baseline for subjective symptom frequency score ( P=0.0376 , primary endpoint ) and objective fluorescein staining score ( P=0.0074 , secondary endpoint ) . 0.18 % SH had an excellent safety profile over 84 days . A strong trend was observed in favour of 0.18 % SH to cause less blurred vision than carbomer throughout the trial ( P=0.0798 at Day 28 ) . CONCLUSION 0.18 % SH caused a statistically significant improvement in both a subjective endpoint ( symptom frequency score ) and an objective endpoint ( fluorescein staining score ) . 0.18 % SH was well tolerated and result ed in low incidence of adverse events PURPOSE To assess the effect of oral omega-3 fatty acids on tear break-up time ( TBUT ) , Schirmer 's score , and Ocular Surface Disease Index ( OSDI ) through a double-blind clinical trial . DESIGN R and omized , double-blind clinical trial . PARTICIPANTS Sixty-four patients with dry eye symptoms between the ages of 45 and 90 years were r and omized into 2 groups : 33 persons in the treatment group and 31 persons in the placebo group . METHODS The treatment group received 2 capsules of omega-3 ( each containing 180 mg eicosapentaenoic acid [ EPA ] and 120 mg docosahexaenoic acid [ DHA ] ) daily for 30 days , and the placebo group received 2 medium-chain triglyceride oil capsules daily for 1 month . The outcomes were measured 1 month after the intervention . MAIN OUTCOME MEASURES The primary outcome measure was an increase from baseline in TBUT at day 30 . Secondary outcome measures were a decrease from baseline in the OSDI score and an increase in the Schirmer 's score at day 30 . RESULTS In the placebo group , before the intervention , the mean TBUT , OSDI , and Schirmer 's scores were 4.5 ± 2.1 seconds , 36.4 ± 13.8 , and 6.0 ± 2.6 mm , respectively , and 1 month later were 4.7 ± 2.6 seconds , 37.6 ± 13.5 , and 6.2 ± 2.5 mm , respectively . In the treatment group , these values were 3.9 ± 1.7 seconds , 38.7 ± 16.5 , and 5.8 ± 2.5 mm before the intervention and 5.67 ± 2.6 seconds , 29.3 ± 15.9 , and 6.8 ± 2.8 mm after the intervention , respectively . Repeated- measures analysis of variance showed that improvements in TBUT , OSDI , and Schirmer 's scores were significantly better in the treatment group than in the placebo group . The changes in the treatment and placebo groups were 71 % and 3.3 % for TBUT ( P < 0.001 ) , 26 % and 4 % ( P=0.004 ) for dry eye symptoms , and 22.3 % and 5.1 % for Schirmer 's score ( P=0.033 ) , respectively . CONCLUSIONS This study demonstrated that oral consumption of omega-3 fatty acids ( 180 mg EPA and 120 mg DHA twice daily for 30 days ) is associated with a decrease in the rate of tear evaporation , an improvement in dry eye symptoms , and an increase in tear secretion Purpose : To investigate the effects of diquafosol sodium ( DQS ) eye drops , a purinergic P2Y2 receptor agonist , on tear film stability in patients with unstable tear film ( UTF ) . Methods : Two prospect i ve studies were conducted . One was an exploratory nonr and omized trial on 39 eyes with dry eye symptoms and short tear film break-up time ( BUT ) , but without epithelial damage .  Changes in symptoms , BUT , Schirmer value , and ocular surface fluorescein staining ( FS ) scores were studied for 3 months . The other was a r and omized clinical trial of DQS and artificial tears ( AT ) in 17 eyes with short BUT . Eyes with decreased Schirmer values ( ⩽5 mm ) were excluded . Changes in symptoms , BUT , FS scores , and tear film stability using continuous corneal topographic analysis were studied for 4 weeks . Results : In the exploratory study , while Schirmer values were not significantly increased , significant improvements in symptoms and BUT were noted at both 1 and 3 months . In the r and omized clinical trial , significant improvements in symptoms were noted in the DQS group , but not in the AT group , at 2 weeks . BUT was significantly prolonged in the DQS group at 4 weeks but not in the AT group . No significant changes were noted in FS scores or tear film stability . Conclusions : DQS improved subjective symptoms and prolonged BUT in eyes with UTF not associated with low tear secretion and ocular surface epithelial damage . Because many patients who have UTF are refractory to conventional treatments , DQS may offer benefits in the treatment of dry eyes Purpose : We compared the efficacy and safety of sodium hyaluronate ( SH ) and carboxymethylcellulose ( CMC ) in treating mild to moderate dry eye . Methods : Sixty-seven patients with mild to moderate dry eye were enrolled in this prospect i ve , r and omized , blinded study . They were treated 6 times a day with preservative-free unit dose formula eyedrops containing 0.1 % SH or 0.5 % CMC for 8 weeks . Corneal and conjunctival staining with fluorescein , tear film breakup time , subjective symptoms , and adverse reactions were assessed at baseline , 4 weeks , and 8 weeks after treatment initiation . Results : Thirty-two patients were r and omly assigned to the SH group and 33 were r and omly assigned to the CMC  group . Both the SH and CMC groups showed statistically significant improvements in corneal and conjunctival staining sum scores , tear film breakup time , and dry eye symptom score at 4 and 8 weeks after treatment initiation . However , there were no statistically significant differences in any of the indices between the 2 treatment groups . There were no significant adverse reactions observed during follow-up . Conclusions : The efficacies of SH and CMC were equivalent in treating mild to moderate dry eye . SH and CMC preservative-free artificial tear formulations appropriately manage dry eye sign and symptoms and show safety and efficacy when frequently administered in a unit dose formula Purpose To compare a treatment containing carboxymethylcellulose ( CMC ) and the osmoprotective ( OsPr ) compatible osmolytes erythritol , L-carnitine , and glycerin ( OsPr-CMC ) with a st and ard sodium hyaluronate ( Na-HY ) formulation in patients with dry eye disease . Methods This was a 3-month , phase III , noninferiority study . Patients were r and omized 1:1 to receive OsPr-CMC ( OPTIVE ® ) or Na-HY ( VISMED ® ) . The primary efficacy outcome was the mean change from baseline in total ocular staining at day 35 , scored using the 15-point Oxford scale . Noninferiority was assessed using the adjusted means . The secondary efficacy outcome was change in ocular surface disease index ( OSDI ) score from baseline to day 35 . Other outcomes included tear osmolarity , Schirmer-I test score , OSDI , ease of use , patient acceptability , tolerability , and safety . Results A total of 82 patients were r and omized . The primary efficacy analysis was per protocol ( OsPr-CMC , n=37 ; Na-HY , n=29 ) . OsPr-CMC was noninferior to Na-HY in terms of adjusted mean change ( SE ) in ocular staining score at day 35 : −2.0 ( 0.33 ) with OsPr-CMC vs −1.7 ( 0.37 ) with Na-HY . Similar improvements were seen in tear osmolarity , Schirmer-I test score , OSDI , and ocular staining for OsPr-CMC and Na-HY . More patients treated with OsPr-CMC vs Na-HY liked using their eyedrops , reported that their eyes felt comfortable , and found the treatment easy to use . Both treatments were well tolerated , with no serious treatment-related adverse events . Conclusions Compared with Na-HY , OsPr-CMC was noninferior in terms of efficacy and safety , preferred by patients , and easier to use . Osmoprotection using OsPr-CMC therefore represents a viable option for dry eye disease management Purpose : Synergistic interactions between hyaluronic acid ( HA ) and tamarind seed polysaccharide ( TS-polysaccharide ) have been demonstrated by means of nuclear magnetic resonance spectroscopy . This study was design ed to investigate the potential clinical benefit of a combination of HA and TS-polysaccharide in managing dry eye disease ( DED ) . Methods : A total of 49 subjects with moderate DED , confirmed by Ocular Surface Disease Index ( OSDI ) question naire score between 10 and 25 , tear break-up time ( BUT ) < 10 seconds , or Schirmer I test < 5.5 mm after 5 minutes , and lissamine green staining of the ocular surface > 2 according to National Eye Institute score system , were enrolled into this multicenter , r and omized , double-masked study to receive either combination of HA and TS-polysaccharide or carmellose sodium for 3 months , both instilled 4 times per day . The assessment s included OSDI question naire , tear film stability ( BUT ) , tear production ( Schirmer I test ) , and corneal and conjunctival staining . Results : Patients treated with HA and TS-polysaccharide showed a statistically significant improvement in the OSDI score at the end of the study compared to the baseline and control groups . The HA and TS-polysaccharide and carmellose sodium were equally effective in reducing BUT and the extent of injury assessed by corneal and conjunctival staining . Non-significant changes were recorded for Schirmer I test . Conclusions : Based on the results of this clinical trial , the combination of HA and TS-polysaccharide appears to be effective in improving the symptoms of dry eye , opening new scenarios in possible treatment of the disease by combining different molecules AIM To evaluate the effects of acupuncture in patients with keratoconjunctivitis sicca ( KCS ) . MATERIAL AND METHODS Twenty-five patients ( 20 women , five men ) with KCS were r and omly assigned to an acupuncture treatment group or a control group . The effects of acupuncture were evaluated by a question naire on symptoms , visual analogue scale recordings , registration of drop frequency , and dry eye tests . Ten acupuncture sessions were given . Follow-up was carried out after 2 - 3 weeks and again after a mean period of 8 months . RESULTS Patients receiving acupuncture felt better at the first follow-up compared with the control group ( p = 0.036 ) . However , no statistical significance could be found concerning any change , or difference , in the total number of subjective symptoms , dosage frequency or , as indicated by the dry eye tests , tear quality , tear secretion and ocular surface disease . CONCLUSION The results indicate that acupuncture has subjective beneficial effects in patients with KCS and could therefore be tried as a complement to ordinary treatment OBJECTIVE To assess the safety and potential efficacy of etanercept in the treatment of Sjögren 's syndrome ( SS ) . METHODS This pilot study was a 12-week r and omized , double-blind , placebo-controlled trial of  etanercept , with 14 subjects in each group . Patients received 25 mg of etanercept or placebo ( vehicle ) by twice-weekly subcutaneous injection . Patients met the American-European Consensus Group criteria for SS . The primary outcome required at least 20 % improvement from baseline values for at least 2 of the following 3 domains : subjective or objective measures of dry mouth , subjective or objective measures of dry eyes , and IgG level or erythrocyte sedimentation rate ( ESR ) . RESULTS Of the 14 patients taking etanercept , 11 had primary SS and 3 had SS secondary to rheumatoid arthritis . Baseline measures did not differ between the 2 groups . Three etanercept-treated patients and 1 placebo-treated patient did not complete the trial . Five etanercept-treated patients and 3 placebo-treated patients showed improvement from baseline in the primary outcome variable at 12 weeks , but the difference was not statistically significant . There were no significant differences between the groups for changes in subjective measures of oral or ocular symptoms ( by visual analog scale ) , the IgG level , Schirmer I test result , van Bijsterveld score , or salivary flow . At 12 weeks , the ESR had decreased in the etanercept group compared with baseline ( P = 0.004 ) ; however , the mean reduction was only 18.6 % . CONCLUSION We found no evidence to suggest that treatment with etanercept at a dosage of 25 mg twice weekly for 12 weeks was clinical ly efficacious in SS . A larger trial will be necessary to definitively address the efficacy of etanercept in the treatment of SS Purpose : We report the results of 3 studies conducted to evaluate the performance of a 1.0 % carboxymethylcellulose ( CMC ) mid-viscosity artificial tear compared to currently marketed low-viscosity tears . Methods : First , a single-center , double-masked , r and omized , crossover study was performed to compare the effect on the Ocular Protection Index ( OPI ) of the mid-viscosity tear compared to low-viscosity tears in 39 subjects with mild to moderate dry eye . Second , a 1-month , 2-arm , parallel , r and omized double-masked clinical study assessed objective signs and subjective symptoms of dry eye in 103 subjects with mild to moderate dry eye . Third , in a 1-month home-use test , 465 artificial tear users compared the mid-viscosity tear or a current low-viscosity tear to their current artificial tear . Results : The OPI study showed prolonged tear breakup time and improved OPI for at least 20 minutes after instillation of the mid-viscosity tear . The low-viscosity tears showed improvements for 5 to 10 minutes . The 1-month clinical study showed a significant reduction in staining and dry eye symptoms after 1 week of treatment , with a further reduction in staining after 1 month in the mid-viscosity group . Subjects provided more reports of blur with the mid-viscosity tear than with a low-viscosity tear , but equivalent overall acceptability . The home use test showed general acceptability of the mid-viscosity tear , including more subjects indicating that it was needed less frequently than their prior low-viscosity tear . Conclusions : This 1 % CMC mid-viscosity tear showed protection of the ocular surface after instillation and significant reduction in signs and symptoms of dry eye . Improvements were greater than with low-viscosity tears . The mid-viscosity artificial tear was rated well in comfort , duration of benefit , and general acceptability BACKGROUND With the underst and ing of the immune inflammatory response in the pathogenesis of dry eyes , and the limitations of widely used artificial tears and numerous pharmaceuticals and methods to promote tear secretion , clinicians pay more attention to the therapies that can promote tear secretion actively . Acupuncture treatment for dry eye may meet this requirement . OBJECTIVE To observe the clinical efficacy of acupuncture treatment on dry eye and the effects on duration , and to examine the mechanisms of acupuncture in treating patients with dye eyes . DESIGN , SETTING , PARTICIPANTS AND INTERVENTIONS The study was performed at Department of Ophthalmology , Shuguang Hospital , Shanghai University of Traditional Chinese Medicine from August 2010 to May 2011 . Patients with the primary diagnosis of dry eye were enrolled . Sixty-five patients were r and omly divided into treatment group and control group , and were given 3 weeks of acupuncture treatment or artificial tear therapy respectively . MAIN OUTCOME MEASURES The enzyme-linked immunosorbent assay was used to detect the lactoferrin content of the tears before and after treatment . In order to evaluate the efficacy of the treatment methods , the Schirmer I test and break-up time were also measured . RESULTS Compared with before treatment , the lactoferrin content in the tears of patients in the treatment group increased , break-up time was prolonged and the result of the Schirmer I test showed improvement after 3 weeks of treatment . The indexes mentioned above did not change in the control group after treatment . There were no significant differences in tear lactoferrin and Schirmer I test between one week after treatment and after 3-week treatment in the treatment group , but break-up time was significantly shortened . The result of Schirmer I test in the treatment group was significantly higher than that in the control group one week after treatment . CONCLUSION Acupuncture can increase tear lactoferrin level , extend tear film break-up time and promote tear secretion in patients with dry eye in a time-limited trial . With the end of treatment , the effect decreased OBJECTIVE To probe into a treatment method for increasing clinical therapeutic effect on xerophthalmia . METHODS Forty-five cases were r and omly divided into acupuncture group 1 , acupuncture group 2 and control group . The acupuncture group 1 were treated with acupuncture based on syndrome types , and the acupuncture group 2 with acupuncture at local acupoints , and the control group with dripping of artificial tears .  Local symptoms of eyes , S1 T , BUT and FL were observed before and after treatment . RESULTS S1 T and BUT increased after treatment in the two groups ( P < 0.01 , P < 0.05 ) , but did not significantly change in the control group ( P > 0.05 ) . There were significant differences in change of FL as the control group compared with the acupuncture group 1 and 2 . The total effective rate was 86.7 % , 66.7 % and 33.3 % in the acupuncture group 1 , 2 and the control group , respectively . CONCLUSION The integral syndrome differentiation acupuncture can improve secretion of tear , increase stability of tear film , improve local symptoms of eyes with a therapeutic effect better than acupuncture at local acupoints and artificial tears Summary The present study aim ed to compare the clinical efficacy of a 0.4 % carbomer gel and 1 % carboxymethyl cellulose ( CMC ) containing artificial tears in treatment of dry eye patients . Sixty subjects with mean age of 45.89 years who had symptoms and signs of dry eye were enrolled in this prospect i ve , investigator-masked and stratified r and om sampling study . The subjects were divided into two parallel groups with 30 subjects ( 60 eyes ) in each group . One group received carbomer gel , and the other group received 1 % CMC containing artificial tears . Subjects received the drops 3 to 4 times or more per day for 3 months . At the first visit time , the precorneal residence time of these two drops was measured . The efficacy was assessed by comparing the subjective symptoms ( ocular dryness , foreign body sensation , burning sensation and pain ) , and the objective test results of tears breakup time , Schirmer ’s test and corneal fluorescein staining prior to the study and after the treatment . As a result , the ocular residence time of carbomer gel was significantly longer than that of 1 % CMC ( P<0.001 ) . Most of the primary subjective symptoms and objective test results were improved after treatment in both carbomer gel group and 1 % CMC group . As to the improvement of each symptom and objective test result , carbomer gel was more effective than 1 % CMC group ( P<0.01 ) . In conclusion , carbomer gel had longer precorneal residence time and was more effective than 1 % CMC in the treatment of patients with dry eyes INTRODUCTION Inflammation is one of the main mechanisms common to all forms of dry eye . Since polyunsaturated acids are known to show biological anti-inflammatory properties , the aim of this study was to evaluate the efficacy of dietary n-6 and n-3 fatty acids in patients suffering from ocular dryness . PATIENTS AND METHODS One hundred and eighty-one patients diagnosed with bilateral moderate dry eye who were already treated with lachrymal substitutes were r and omized in a double-blind international study to receive placebo or Nutrilarm ( ® ) capsules ( combination of omega-3 and omega-6 ) , twice a day for 6 months . In all subjects , dryness feeling , overall subjective comfort , and ocular symptoms ( burning , stinging , s and y and /or gritty sensation , light sensitivity , reflex tearing , and ocular fatigue ) were evaluated at each visit . Furthermore , fluorescein tests ( break-uptime and Oxford scheme ) and lissamine green test were performed at each visit . The Schirmer test was performed at inclusion and after 6 months of treatment . RESULTS After 6 months of supplementation with Nutrilarm ( ® ) , both the BUT scores and ocular fatigue were significantly improved when compared with placebo ( P=0.036 and P=0.044 , respectively ) . There was a trend in favor of Nutrilarm ( ® ) in terms of the efficacy evaluated by the investigator ( P=0.061 ) . Fewer patients experienced a feeling of severe dryness with Nutrilarm ( ® ) compared with placebo after 6 months of treatment ( 2.5 and 9.3 % , respectively ) , but the difference was not statistically significant . CONCLUSION Oral administration of a double supplementation dietary n-6 and n-3 fatty acids present an additional therapeutic advantage in patients suffering from ocular dryness who were already treated with lachrymal substitutes PURPOSE To assess the prognosis of dry eye in patients treated with cyclosporine 0.05 % or artificial tears  by using the International Task Force ( ITF ) guidelines . METHODS This was a single-center , investigator-masked , prospect i ve , r and omized , longitudinal trial . Dry eye patients received twice-daily treatment with either cyclosporine 0.05 % ( Restasis ; Allergan , Inc. , Irvine , CA ; n = 36 ) or artificial tears ( Refresh Endura ; Allergan , Inc. , Irvine , CA ; n = 22 ) for 12 months . Disease severity was determined at baseline and month 12 according to the consensus guidelines developed by the ITF . Dry eye signs and symptoms were evaluated at baseline and months 4 , 8 , and 12 . RESULTS Baseline sign and symptom scores and the proportion of patients with the disease severity level 2 or 3 were comparable in both groups ( P > 0.05 ) . At month 12 , 34 of 36 cyclosporine patients ( 94 % ) and 15 of 22 artificial tear patients ( 68 % ) experienced improvements or no change in their disease severity ( P = 0.007 ) while 2 of 36 cyclosporine patients ( 6 % ) and 7 of 22 artificial tears patients ( 32 % ) had disease progression ( P < 0.01 ) . Cyclosporine 0.05 % improved Schirmer test scores , tear breakup time , and Ocular Surface Disease Index scores throughout the study , with significant ( P < 0.01 ) differences compared with artificial tears being observed at months 8 and 12 . CONCLUSIONS Treatment with cyclosporine 0.05 % may slow or prevent disease progression in patients with dry eye at severity levels 2 or 3
Importance Dry eye is a common ocular surface condition with significant influence on patient quality of life and societal economic burden .
There is an urgent need to prioritize new research for dry eye .
Objective To identify and rank research questions and outcomes important to patients with dry eye .