July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
DREAM Extension Study - Comparison of placebo and omega-3 fatty acid supplement groups on OSDI, 4 key signs of DED and adverse events
Author Affiliations & Notes
  • Munira Hussain
    Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, Michigan, United States
  • Roni M Shtein
    Ophthalmology and Visual Sciences, University of Michigan, Ann Arbor, Michigan, United States
  • Maxwell Pistilli
    Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Maureen G Maguire
    Ophthalmology, University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Penny A Asbell
    Ophthalmology, University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Footnotes
    Commercial Relationships   Munira Hussain, None; Roni Shtein, None; Maxwell Pistilli, None; Maureen Maguire, None; Penny Asbell, Alcon (C), Alcon (R), Allakon (C), CLAO (C), Dompe (C), Kala (C), MC2 (F), Medscape (C), Miotec (R), Novaliq (C), Regeneron (C), Santen (C), Santen (R), Senju (C), Shire (C), Sun Pharma (C)
  • Footnotes
    Support  Supported by cooperative agreements U10 EY022879, U10 EY022881 from the National Eye Institute and supplemental funds from the Office of Dietary Supplements, National Institutes of Health, Department of Health and Human Services.
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 6729. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to authenticated users only.
      Sign In or Create an Account ×
    • Get Citation

      Munira Hussain, Roni M Shtein, Maxwell Pistilli, Maureen G Maguire, Penny A Asbell; DREAM Extension Study - Comparison of placebo and omega-3 fatty acid supplement groups on OSDI, 4 key signs of DED and adverse events. Invest. Ophthalmol. Vis. Sci. 2019;60(9):6729.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : To determine the effects of continued use or discontinuation of omega-3 (ω3) fatty acid supplements through a randomized withdrawal trial among subjects assigned to ω3 supplements in the first year of the DREAM study.

Methods : A prospective, multi-center, clinical trial was conducted with patients with moderate to severe dry eye disease. Patients who were initially randomized to 3000 mg of ω3 for 12 months in the primary trial were randomized 1:1 to receive ω3 as the active supplement or olive oil as placebo for an additional 12 months. The primary outcome was a mean change from baseline (month 12 of the primary trial) in the score on the Ocular Surface Disease Index (OSDI). Secondary outcomes included changes in the conjunctival staining score, corneal staining score, tear break-up time, Schirmer’s test and incidence of adverse events.

Results : A total of 21 patients were assigned to the ω3 group and 22 to the placebo group. The mean change in the total OSDI score was not significantly different between the ω3 group and the placebo group (mean difference in change -0.6 points, 95% confidence interval [CI], −10.7 to 9.5, p= 0.91). There were no significant differences between the ω3 group and the placebo group in mean changes from baseline in the conjunctival staining score (mean difference in change -0.5 points; 95% CI, −1.1 to 0.0), corneal staining score (-0.6 point; 95% CI, −1.4 to 0.2), tear break-up time (-0.8 seconds; 95% CI, −2.7 to 1.1) and Schirmer’s test (1.2 mm, 95% CI, −0.9 to 3.2). Rates of adverse events were similar in both the groups.

Conclusions : Among patients who received ω3 supplements for 12 months in the primary trial, patients discontinuing the use of ω3 for 12 months did not have significantly worse outcomes compared to those who continued ω3 for an additional 12 months. These results are consistent with the findings from the primary clinical trial of no beneficial effect of ω3 relative to placebo.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×