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

Abstract

Purpose: To determine effects of continued or discontinued use of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among patients assigned to ω3 supplements in the first year of the DREAM study.

Methods: Patients who were initially assigned to ω3 (3000 mg) for 12 months in the primary trial were randomized 1:1 to ω3 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 ω3 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 ω3 supplements for 12 months in the primary trial, those discontinuing use of ω3 for an additional 12 months did not have significantly worse outcomes compared to those who continued use of ω3. ClinicalTrials.gov number NCT02128763.

Keywords: Dry eye disease; Omega-3 fatty acids; Randomized clinical trial.

Copyright © 2019 Elsevier Inc. All rights reserved.

Figures

Figure 1.

Schematic overview of the DREAM primary and extension trials

Figure 2.

Ocular Surface Disease Index (OSDI) scores over time. Box and whisker plots: Box upper and lower edges correspond to the 75th and 25th percentiles, respectively. Within the box, the asterisk corresponds to the mean value and the line corresponds to the 50th percentile (median). Ends of whiskers correspond to the lowest score within 1.5 times the interquartile range of the 25th percentile and the highest score within 1.5 times the interquartile range of 75th percentile. Each circle outside of the whiskers corresponds to one score.

Figure 3.

Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.

Figure 3.

Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.

Figure 3.

Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.

Figure 3.

Signs of dry eye disease over time by treatment group. Mean values and associated 95% confidence intervals for signs of dry eye disease by treatment group, over time. Dotted lines connect values prior to randomization in the extension trial. A. Conjunctival staining; B. Corneal staining; C. Tear break-up time; D. Shirmer test.