Topical Omega-3 Polyunsaturated Fatty Acids for the Treatment of Dry Eye – Results from a Pilot Randomized Controlled Masked-Observer Study

Abstract

To investigate the efficacy, safety and tolerability of topical omega-3 polyunsaturated fatty acids (PUFA) as an innovative treatment of dry eye disease (DED). Patients and Methods: In a pilot, multicenter, masked-observer, randomized, active-controlled, non-inferiority study in Germany, patients self-treated their eyes with daily instillations of eye drops containing either omega-3 PUFA or povidone as major components for three months. At four and twelve weeks, efficacy was among others evaluated based on Ocular Surface Disease Index (OSDI), ocular surface symptoms intensity, general clinical impression, tear break-up time (TBUT), corneal fluorescein staining using the Oxford grading scale, tear volume, and matrix metalloproteinase-9 (MMP-9) concentration in the tear film. Safety evaluation included visual acuity, intraocular pressure, and the incidence of adverse events. Co-primary endpoints were the mean percent changes from baseline of TBUT and OSDI after four weeks. Results: In total 80 patients were included, of whom 37 in the PUFA group and 39 in the povidone group were evaluable for the coprimary endpoints. Patients had a mean age of 52 years and >80% were women. Both co-primary endpoints (TBUT and OSDI) significantly improved from baseline in both treatment groups, at Week 4 and Week 12 and the statistical analysis demonstrated topical omega-3 PUFA to be non-inferior to 2% povidone for these two parameters. Both treatments resulted in a significant improvement of most secondary efficacy endpoints as well, often with a slight difference in favor of PUFA, not reaching statistical significance though. One non-severe, treatment-related local AE was reported in each group. Conclusion: Omega-3 PUFA-based eye drops proved to be non-inferior to povidone-containing eye drops in the treatment of signs and symptoms of dry eye. This treatment may thus be an additional tool for the management of DED.

Nutritional Factors: Benefits in Glaucoma and Ophthalmologic Pathologies

“…Omega-3 FA supplementation is equally efficacious for managing dry eye symptoms triggered by the chronic instillation of antiglaucoma drops [ 100 ]. Subsequently, management possibilities using the innovative topical administration of the omega-3 FAs have been assessed [ 101 ]. It has also been suggested that an adjunctive antioxidant and multivitamin supplementation with docosahexaenoic and eicosapentaenoic fatty acids decreases the risk of progression from early to late age-related macular degeneration (ARMD) [ 102 , 103 ].…”

Exploring the Efficacy of Omega-3 Fatty Acid Supplementation in Dry Eye Disease: A Comprehensive Review

“…Computer hygiene is also emphasized, encouraging frequent blinking and regular breaks to alleviate symptoms [1,13]. In cases where the above methods fail to provide sufficient relief and the dry eye syndrome is severe, second-line treatments involving corticosteroids or cyclosporine may be considered [14].…”