Penny A. Asbell
The Dry Eye Assessment and Management Study Research Group concluded that patients with dry eye who received 3,000 mg of fish-derived n-3 fatty acids for 12 months had no significantly better outcomes than patients who received an olive oil placebo.
According to the researchers, the 27-center, double-masked, randomized study was designed to include a broad range of patients with symptomatic moderate to severe dry eye disease.
At baseline, subjects were an average of 58 years old (active group: 58.3+13.5 years, placebo group: 57.5+12.6 years), had a total Ocular Surface Disease Index (OSDI) score of 44.6+14.0 for active and 44.1+14.6 for placebo, and were primarily female, according to the study. Subjects had signs of dry eye in at least one eye as determined by at least two of four methods: conjunctival staining score, corneal staining score, tear break-up time and Schirmer’s testing.
Study sponsor NIH stated in a press release that all subjects were permitted to continue taking any previous medications for dry eye, including artificial tears and prescription anti-inflammatory eye drops.
“Omega-3s are generally used as add-on therapy,” study chair Penny A. Asbell, MD, said in the release. “The study results are in the context of this real-world experience of treating symptomatic dry eye patients who request additional treatment.”
Three hundred twenty-nine patients received five soft gelatin capsules of 400 mg of eicosapentaenoic acid (EPA) and 200 mg of docosahexaenoic acid (DPA) for a total daily dose of 2,000 mg of EPA and 1,000 mg of DHA, according to the study. One hundred seventy patients received five capsules containing 1,000 mg of refined olive oil (68% oleic acid, 13% palmitic acid and 11% linoleic acid) per day.
After 12 months of treatment, researchers said they found no significant difference between the two groups in the mean change in OSDI score, the primary outcome, which decreased a mean of 13.9 points in the active group and a mean of 12.5 points in the placebo group. They also reported no significant differences in the mean changes in the secondary outcomes, which included conjunctival staining score, corneal staining score, tear break-up time and Schirmer’s test.
They also reported rates of adverse events to be similar in the two groups.
“The results of the DREAM study do not support use of omega-3 supplements for patients with moderate to severe dry eye disease,” Asbell concluded in the press release.
Maureen G. Maguire, PhD, leader of the coordinating center for the study, added: “The findings also emphasize the difficulty in judging whether a treatment really helps a particular dry eye patient.” – by Nancy Hemphill, ELS, FAAO
Disclosures: The study was funded by the NEI and NIH. Asbell reported receiving financial support from Allergan, Bausch + Lomb/Valeant, MC2 Therapeutics, Miotech, Novartis, Oculus, Rtech, Santen and Shire. Maguire reported no relevant financial disclosures. Please see the full study for all other authors’ financial disclosures.