Optometrists have long recommended omega-3 fatty acid supplements to their patients with dry eye disease. Results from a recent study show that while omega-3s offer benefits, they did not offer significantly better outcomes than an olive oil placebo.
The Dry Eye Assessment and Management (DREAM) study1 was funded by the National Eye Institute, part of the National Institute of Health, and randomized more than 500 patients, following them for more than one year. This well-controlled trial calls into question current thinking that leads ODs to recommend omega-3 supplements to their dry eye patients.
“Every day ODs sit in the trenches, wondering how to deal with new treatments that bombard us,” says Optometry Times Editorial Advisory Board member Milton M. Hom, OD, FAAO. “For years, industry and experts have touted omega-3s for dry eye disease. But now, we have a well-designed, highly powered study showing the exact opposite results.”
Dr. Hom served as a principal investigator for the DREAM study; his comments are his own and do not represent the DREAM study.
Study subjects at 27 clinical centers were randomized to the active supplementation group or placebo group; the primary study analysis looked at 349 and 186 patients, respectively.
Eligibility criteria were age 18 years or older, presence of ocular symptoms for at least 6 months, use of or desire to use artificial tears an average of twice per day, and an Ocular Surface Disease Index (OSDI) score of 25 to 80.
Eligible patients also needed two out of four signs of dry eye in at least one eye: conjunctival lissamine green staining score of 1 or more, corneal fluorescein staining score of 4 or more, tear break-up time (TBUT) ≤7 seconds, and Schirmer with anesthesia result of 1 to 7 mm in 5 minutes.
Study subjects took five soft-gelatin capsules per day. Capsules in the active group contained omega-3s with 400 mg EPA and 200 mg DHA; capsules in the placebo group contained 100 mg refined olive oil (68 percent oleic acid, 13 percent palmitic acid, 11 percent linoleic acid). Both capsules also contained 3 mg vitamin E.
Patients in the study were permitted to continue their current dry eye regimens.
Says Penny Asbell, MD, FACS, MBA, study chair for the trial: “One of the good things about DREAM is that there is a lot of consistency. Every symptom group improved, so there was no difference between them. There were slight improvements in three or four of the signs groups, but there was no significant difference among those groups.”
Dr. Asbell is professor of ophthalmology, director of cornea and refractive services, and director of the department of ophthalmology cornea fellowship program at Icahn School of Medicine at Mount Sinai in New York City.
Another strength of the study is that it’s a real-world study, says Dr. Asbell.
“We took patients who were symptomatic despite whatever treatments they might be doing, and they were allowed to continue those treatments,” she says. “It was typical of the kinds of patients I see and other clinicians see in the office every day. We didn’t say you couldn’t do this or you couldn’t do that.”