In the Journals

DREAM study: Omega-3 no better than olive oil for dry eye

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.

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.

    Perspective
    Stuart Richer

    Stuart Richer

    DREAM is a compelling study in every respect except for poor choice of placebo. The olive polyphenols found in healthy Mediterranean diets, i.e., hydroxytyrosol (an ο-diphenol) have powerful anti-inflammatory, antioxidant and antithrombotic properties. This likely explains why the overall direction of both the DREAM omega-3 and DREAM olive oil arms were positive, yet statistically insignificant when compared to each other.

    The Alienor Study of olive oil consumption and age-related macular degeneration taught us that this vegetable oil has potency against AMD (Cougnard-Grégoire A et al.). After adjustment for potential confounders, regular use of olive oil was significantly associated with a decreased risk of late AMD (odds ratio = 0.44, 95% confidence interval: 0.21;0.91). Basic science explains why. Incubating retinal cells with olive oil induces desirable biochemical and biophysical cell-membrane fluidity enhancement, slowing the development of disease (Said et al.). This writer believes that increased olive oil consumption promoted "membrane fluidity” in the research subjects and beneficially affected the rotation and diffusion of epithelial and lacrimal cell proteins/biomolecules over time.

    In DREAM, most dry eye symptoms and signs appear to improve in both arms. In each trial group, there was a meaningful statistical change between baseline and 12 months (with time as a continuous variable) in the conjunctival staining score, the corneal staining score and the tear break-up time (P < 0.001).  Thus, a more accurate description for the DREAM study would be: “Olive oil or omega-3 supplementation in the treatment of dry eye.”

    Omega-3 fatty acids have cardiovascular, anticancer and cognitive benefits, based upon thousands of studies. Let’s not throw fish oil overboard, as it’s a major predictive biomarker of healthy aging.

    References:

    Cougnard-Grégoire A, et al. Plos One. 2016;doi:10.1371/journal.pone.0160240.

    Said T, et al. Can J Physiol Pharmacol. 2013:doi.org/10.1139/cjpp-2013-0036.

    • Stuart Richer, OD, PhD, FAAO
    • Director, ocular preventive medicine,
      James Lovell Federal Health Care Facility, Chicago
      Associate professor, family and preventive medicine,
      Chicago Medical School
      Assistant clinical professor, department of ophthalmology
      and visual science, University of Illinois at Chicago
      Member, Primary Care Optometry News Editorial Board

    Disclosures: Richer reports he is global scientific director of the Zeaxanthin Trade Association and president of the Ocular Wellness and Nutrition Society. He receives research funding from ZeaVision and consults for Bausch + Lomb, Douglas Labs, Eyecheck and Stereo Optical.