An open-label randomized clinical trial to evaluate the efficacy and tolerability of flax seed nutritional supplementation in comparison with omega-3 fatty acid capsule in mild dry eye disease

Background: Dry eye disease (DED) is a multifactorial disease commonly encountered in ophthalmology clinics. Omega-3 fatty acid has been proved to be effective in improving the symptoms of DED. Flax seed being the richest plant source of alpha-linolenic acid can be effective in DED. Aims: To evaluate the efficacy and tolerability of flax seed supplementation in comparison with omega-3 fatty acid capsules in DED. Setting and Design: Single-center randomized open-label clinical trial done at tertiary care hospital. Subjects and Methods: Two hundred sixty-eight subjects with clinically diagnosed mild dry eye received either flax seed supplementation daily for 3 months or omega-3 fatty acid capsule once daily for 3 months. Patients were evaluated at baseline, week 4, week 8, and week 12. On each visit subjects filled ocular surface disease index (OSDI) questionnaire and underwent Schirmer test, tear break up time (TBUT) and ocular staining. Results: One hundred thirty-three patients received flax seeds and 135 received omega-3 fatty acid. Schirmer test and TBUT showed increase in scores at each visit. OSDI scores reduced at subsequent visit and were statistically significant. Two factor repeated measures analyses of variances showed no statistically significant difference between the groups in terms of OSDI scores (P = 0.018). Conclusion: Our study demonstrated a rapid response to nutritional therapy (with flax seeds and omega-3 fatty acid capsules) in alleviating the signs and symptoms of dry eyes in both the groups. Flaxseeds supplementation is comparable to omega-3 fatty acid supplementation in DED and thus forms the cost-effective treatment for dry eyes and can be considered as an adjunctive therapy for the same.