Patients
Conjunctival Redness, blepharitis, ocular allergies, ocular infection, Conjunctival redness
INFLAMMATION, DRY EYE, BLEPHARITIS, MEIBOMIAN GLAND DYSFUNCTION, EYE, OCULAR INFECTION
Enrolled patients were adults with mild, moderate, or severe DED. Major selection criteria are shown in Major Patient Selection Criteria≥18 years of ageReported history of dry eye and had used or desired to use eye drops to treat the condition for ≥6 months before the first treatment visitOn treatment visits 1 and 2 patients had to have
○ BCVA of ≥0.7 logMAR (Snellen equivalent score of ≥20/100)○ Score of ≥2 on the Ora Calibra○ Schirmer's test score of ≤10 and ≥1 mm○ Corneal fluorescein staining score of ≥2 in any corneal region (inferior, central, or superior) according to the Ora Calibra Corneal and Conjunctival Staining Scale for Grading of Fluorescein Staining in ≥1 eye○ Conjunctival redness score ≥1 according to the Ora Calibra Conjunctival Redness for Dry Eye Scale in ≥1 eye (2-week visit pre-CAE)Demonstrated response to CAE at baseline and 2-week visit in the same eye(s)○ ≥1 point increase in fluorescein staining in the inferior region in ≥1 eye after CAE exposure○ Ocular Discomfort score ≥3 at ≥2 time points in ≥1 eye during CAE exposureClinically significant slit-lamp findings at screening, including active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that required therapeutic treatment or would interfere with studyBeen diagnosed with an ongoing ocular infection or active ocular inflammationWorn contact lenses within 7 days of screening or planned to wear LASIK surgery performed within 12 months, ocular and/or lid surgeries in past 6 months or planned during the studyLaser procedures in the previous 3 monthsUse of cyclosporine or lifitegrast ophthalmic solutions within 60 days of screeningUse of or anticipated use of temporary punctal plugs during study that were not stable within 30 days of screeningUnable to discontinue topical ophthalmic prescriptions for the duration of the trialAt least 1 eye (same eye) had to satisfy all these criteria.BCVA, best-corrected visual acuity; CAE, controlled adverse environment; logMAR, logarithm of the minimum angle of resolution.