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Results of a randomized, clinical trial provide evidence to support use of a proprietary oral supplement containing omega-3 fatty acids as a mainstay in the management of dry eye disease.
Dallas-Results of a randomized, double-masked, vehicle-controlled clinical trial provide evidence to support use of a proprietary oral supplement containing omega-3 fatty acids (TheraTears Nutrition, Advanced Vision Research) as a mainstay in the management of dry eye disease, said James P. McCulley, MD.
To be eligible for participation, patients could have no systemic diseases or any medication use that could contribute to their dry eye, nor could they have slit-lamp evidence of significant ocular surface inflammation.
After a run-in period with artificial tears, patients underwent a battery of baseline evaluations to assess the ocular surface, tear dynamics, meibomian lipid composition, and symptoms.
They were randomly assigned to receive 3 months of treatment with vehicle or the dietary supplement that contains 450 mg eicosapentaenoic acid, 300 mg docosahexaenoic acid, and 1,000 mg of flaxseed oil.
Analyses from data collected in repeat testing performed at the end of treatment showed significant benefits favoring the omega-3 supplement group for greater symptomatic improvement and increased tear production.
At study completion, 70% of patients using the omega-3 supplement became asymptomatic compared with just 7% of the control group.
There were no treatment-related differences in tear lipid composition, and subgroup analyses showed no differences in the responses of patients with and without associated MGD. There were no adverse effects associated with omega-3 supplement use, according to Dr. McCulley.
"I believe, as do others, that omega-3 fatty acids have positive general health effects, and the results of this study show a benefit for supplementation with this particular product in patients with dry eye disease," Dr. McCulley said.
"Considering this efficacy and the demonstrated safety, I include oral omega-3 supplementation combined with artificial tears as standard treatment for all patients with dry eye disease, and I recommend this particular omega-3 product because I have evidence that it works," he added.
Dr. McCulley has a long-standing interest in dry eye disease and was motivated to conduct this study because there have been a lot of anecdotal reports describing value of oral omega-3 supplementation for improving dry eye disease, but a lack of controlled clinical trials. The protocol was investigator-initiated, and in seeking industry support for conducting the trial, Advanced Vision Research was the only company contacted that was willing to provide funding.