The Dry Eye Assessment and Management (DREAM) extension study - A randomized clinical trial of withdrawal of supplementation with omega-3 fatty acid in patients with dry eye disease

Purpose: To determine effects of continued or discontinued use of omega-3 (omega 3) fatty acid supplements through a randomized withdrawal trial among patients assigned to omega 3 supplements in the first year of the DREAM study. Methods: Patients who were initially assigned to omega 3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to omega 3 active supplements or placebos (refined olive oil) for 12 more months. The primary outcome was change in the Ocular Surface Disease Index (OSDI) score. Secondary outcomes included change in conjunctival staining, corneal staining, tear break-up time, Schirmer test, and adverse events. Results: Among 22 patients assigned to omega 3 and 21 to placebo supplements, the mean change in OSDI score between month 12 and 24 was similar between treatment groups (mean difference in change - 0.6 points, 95% confidence interval [CI], ( - 10.7, 9.5), p = 0.91). There were no significant differences between groups in mean change in conjunctival staining (difference in mean change -0.5 points; 95% CI ( - 1.2, 0.3)), corneal staining ( - 0.3 points; 95% CI ( - 1.2, 0.3)), tear break-up time ( - 0.8 s; 95% CI ( - 2.6, 0.9)) and Schirmer test (0.6 mm, 95% CI ( - 2.0, 3.2)). Rates of adverse events were similar in both groups. Conclusion: Among patients who received omega 3 supplements for 12 months in the primary trial, those discontinuing use of omega 3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of omega 3.