Results
DRY EYE, EYE
The study included a total of 405 patients from 19 clinical centers with a TearLab Osmolarity System for measuring tear osmolarity. The mean age at enrollment was 58 years (SD = 13), 81% were female, 72% were Caucasian, 10% had Sjögren's disease. The mean (SD) baseline OSDI score was 44 (SD = 14). Patient and ocular characteristics at baseline are presented in Patient Characteristics at BaselineThe mean (SD) tear osmolarity was 303 (SD = 16) mOsm/L at baseline, 303 (SD = 18) mOsm/L at both 6 months and 12 months. Patients randomized to Omega-3 had a higher tear osmolarity than patients in the placebo group at baseline (304 vs. 301 mOsm/L; Tear Osmolarity Measure at Baseline, Six, and 12 Months Over All and by Treatment GroupsAbnormal osmolarity defined as osmolarity >308 mOsm/L in either eye or an inter-eye difference >8 mOsm/L.Comparing the tear osmolarity measured at summer (June, July, August) and winter (December, January, February) among 266 eyes that had osmolarity taken both in summer and winter, there was no statistically significant difference in osmolarity (303 vs. 301 mOsm/L; In the analysis of osmolarity data from baseline and six and 12 months combined, higher osmolarity was associated with older age (306 mOsm/L for age ≥70 years vs. 300 mOsm/L for age <50 years; Association of Baseline Demographics With Osmolarity at Baseline, Six Months, and 12 Months CombinedThe association between tear osmolarity and OSDI was evaluated by analyzing data from baseline and six and 12 months combined (Associations Between Person-Level Osmolarity and OSDI From Analysis of Combined Data From Baseline, Six Months, and 12 MonthsAbnormal osmolarity defined at the person level as >308 mOsm/L in either eye or an intereye difference >8 mOsm/L.The cross-sectional association of tear osmolarity with dry eye signs was evaluated by analyzing combined data from baseline and six and 12 months (Association Between Osmolarity With Dry Eye Signs and Symptoms From Analysis of Combined Data of Baseline, Six Months, And 12 MonthsIn the analysis of person-level osmolarity abnormality (i.e., defined as osmolarity >308 mOsm/L in either eye or an intereye difference >8 mOsm/L) and maximum tear osmolarity from two eyes of a patient for their association with dry eye signs (Association Between Person-Level Osmolarity With Dry Eye Signs and Symptoms From Analysis of Combined Data of Baseline, Six Months, And 12 MonthsAbnormal osmolarity defined at the person level as >308 mOsm/L in either eye or an inter-eye difference >8 mOsm/L.The association of tear osmolarity with keratography measures was analyzed at baseline and six and 12 months combined and separately (See 