Effectiveness and tolerability of dietary supplementation with a combination of omega-3 polyunsaturated fatty acids and antioxidants in the treatment of dry eye symptoms: results of a prospective study

Background: We assessed the effectiveness and tolerability of a dietary supplement based on the combination of omega-3 essential fatty acids and antioxidants on dry eye-related symptoms. Methods: A total of 905 patients (72% women, median age 60 years) with dry eye syndrome and using artificial tears to relieve symptoms participated in an open-label prospective intervention study. They were recruited during a routine ophthalmological appointment. Patients were instructed to take three capsules/day of the nutraceutical formulation (Brudysec (R) 1.5 g) for 12 weeks. Dry eye symptoms (categorized as 0, none; 1, mild; 2, moderate; and 3, severe) included scratchy and stinging sensation in the eyes, eye redness, grittiness, painful eyes, tired eyes, grating sensation, and blurry vision. Results: The mean intensity of dry eye symptoms varied from 1.1 (+/- standard deviation [SD] 0.9) for painful eyes to 2.0 (0.9) for grittiness, with a mean value of 11.9 (4.8) for all symptoms together. At week 12, all individual symptoms improved significantly (P<0.001). The mean value for all symptoms together decreased from a mean value of 11.9 (+/- SD 4.8) at baseline to 6.8 (+/- SD 4.5) after 12 weeks of treatment (P<0.001). There was a decrease in the percentage of patients in which dry eye symptoms predominated nearly all the time (53.5% versus 34.1%). A total of 68.1% of patients reported better tolerance to contact lenses after treatment. The mean number of daily instillations of artificial tears also decreased significantly (3.8 [+/- SD 1.6] versus 3.3 [+/- SD 1.6], P<0.001). A total of 634 patients (70.1%) did not report any adverse events. In the remaining patients with adverse events, the most frequent was fish-tasting regurgitation in 13.5% of cases, followed by nausea in 4.9%, diarrhea in 1.3%, and vomiting in 0.3%. Conclusion: Dietary supplementation with a combination of omega-3 essential fatty acids and antioxidants was an effective treatment for dry eye.