Asbell PA, et al. - Experts evaluated the impacts of n-3 fatty acids (often called omega-3 fatty acids) to relieve symptoms of dry eye disease (characterized by ocular discomfort and visual disturbances). No significantly better outcomes were seen in the patients who were randomly assigned to receive supplements containing 3,000 mg of n-3 fatty acids for 12 months vs those who were assigned to receive placebo.

Methods

• Researchers randomly assigned patients with moderate-to-severe dry eye disease to receive a daily oral dose of 3,000 mg of fish-derived n-3 eicosapentaenoic and docosahexaenoic acids (active supplement group) or an olive oil placebo (placebo group) in a multicenter, double-blind clinical trial.
• The mean change from baseline in the score on the Ocular Surface Disease Index (OSDI; scores range from 0 to 100, with higher scores indicating greater symptom severity), which was based on the mean of scores obtained at 6 and 12 months was the primary outcome.
• Mean changes per eye in the conjunctival staining score (ranging from 0 to 6) and the corneal staining score (ranging from 0 to 15), with higher scores indicating more severe damage to the ocular surface, as well as mean changes in the tear break-up time (seconds between a blink and gaps in the tear film) and the result on Schirmer’s test (length of wetting of paper strips placed on the lower eyelid), with lower values indicating more severe signs were the secondary outcomes.

Results

• As per data, a total of 349 patients were assigned to the active supplement group and 186 to the placebo group; the primary analysis included 329 and 170 patients, respectively.
• Between the active supplement group and the placebo group (-13.9 points and -12.5 points, respectively; mean difference in change after imputation of missing data, -1.9 points; 95% confidence interval [CI], -5.0 to 1.1; P=0.21) the mean change in the OSDI score was not significantly different.
• Findings suggested that this result was consistent across prespecified subgroups.
• Results demonstrated that there were no significant differences between the active supplement group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change, 0.0 points; 95% CI, -0.2 to 0.1), corneal staining score (0.1 point; 95% CI, -0.2 to 0.4), tear break-up time (0.2 seconds; 95% CI, -0.1 to 0.5), and result on Schirmer’s test (0.0 mm; 95% CI, -0.8 to 0.9).
• According to the level of n-3 fatty acids in red cells, the rate of adherence to treatment in the active supplement group was 85.2% at 12 months.
• Authors noted the rates of adverse events to be similar in the 2 trial groups.