A clinical trial supported by the National Eye Institute shows that oral omega-3 is no better than placebo in relieving signs and symptoms of dry eye disease.
The Dry Eye and Assessment Management Study (DREAM) is the first large-scale real-world, double-masked, randomized clinical trial that studies the long-term efficacy and safety of omega-3 supplementation for symptomatic DED.
The researchers enrolled a total of 535 participants with at least a 6-month history of moderate to severe dry eye. Participants were randomly assigned to receive either a daily dose of an omega-3 supplement or an olive oil placebo. Each omega-3 dose contained 2,000 milligrams of EPA and 1,000 milligrams of DHA. Each placebo dose contained 5 grams, or roughly one teaspoon, of olive oil. A total of 349 participants received daily doses of fish-derived omega-3 fatty acids and 186 participants received a daily dose of olive oil. The doses were delivered in identical capsules and neither the patients nor their eye doctors knew which treatment group they were in.
After 12 months, the researchers found that participant’s symptoms had improved substantially in both groups, but there was no significant difference in the degree of symptom improvement between the groups. Overall, 61 percent of people in the omega-3 group and 54 percent of those in the control group achieved at least a 10-point improvement in their symptom score, but the difference between the groups was not statistically significant.
There were no safety issues linked to this supplement when taken for DED and no serious adverse effects.
“DREAM results do not support w3 supplementation for dry eye disease. There is a cost, and the money may be better spent on other treatments for dry eye disease,” Penny Asbell, MD, Study Chair of the NIH-funded DREAM Study, Professor of Ophthalmology at the Icahn School of Medicine at Mount Sinai, and Director of the Cornea and Refractive Surgery Service at The Mount Sinai Hospital, said in a Mount Sinai news release.
“Our findings provide evidence that, contrary to a long held belief in the ophthalmic community, omega-3 supplements are not significantly better than a placebo at reducing dry eye symptoms,” Maureen Maguire, PhD, a professor of Ophthalmology at Penn Medicine and the principal investigator of the Coordinating Center for the study, said in a Penn Medicine news release. “Many patients receiving omega-3 supplements did have substantial improvement in their symptoms, but just as many patients taking placebo had improvements.”
The results are published in the New England Journal of Medicine and presented at the Annual Meeting of the American Society of Cataract and Refractive Surgery in Washington DC.