Abstract
Purpose :
Determine the effect of 6 and 12 months of n-3 fatty acids supplementation on the concentrations of IL-1β, Il-6, IL-8, IL-10, IL-17A, IFNγ and TNFα in tears of dry eye disease (DED) patients enrolled in the Dry Eye Assessment and Management (DREAM) study.
Methods :
In the DREAM study, a multicenter double-blind clinical trial, randomly assigned patients with moderate-to-severe DED received a daily oral dose of 3000 mg of fish-derived n−3 eicosapentaenoic and docosahexaenoic acids (treated group) or refined olive oil (placebo group) for 12 months. Among patients enrolled from sites with sample storage capability, tears were collected from patients at baseline (n=190), 6 months (n=134) and 12 months (n=117). Cytokine levels in the collected tears were determined by a magnetic bead-based multiplex assay. Differences in percent change from baseline in tear cytokine concentration between treatment groups were analyzed with the Wilcoxon rank-sum test.
Results :
At 6 months, a significant difference was found in the response between the treated and placebo group in the levels of cytokines IL-6 and IL-8. The median levels of IL-6 decreased by 29% in the treated group from baseline values as compared to 35.2% increase from baseline in placebo group (p=0.003). The median levels of IL-8 increased by 15.7% from baseline in the treated group as compared to a 79.4% increase from baseline in placebo group (p=0.02) (Figure 1). The significant changes in IL-6 and IL-8 between the two groups did not persist at 12 months post treatment (Figure 2). No changes between the two groups were observed for the other cytokines at 6 and 12 months (Figures 1 and 2).
Conclusions :
Changes in cytokine concentration did not show a consistent or expected expression pattern between placebo and treated patient groups and did not persist over 12 months of treatment. As previously reported, DREAM study patients treated with n-3 fatty acids supplementation had similar outcomes on DED symptoms and signs as compared to the placebo group, consistent with the similar cytokine patterns between the two groups.
This is a 2020 ARVO Annual Meeting abstract.