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Marko Oydanich, Jack V Greiner, Pedram Hamrah, Meng C Lin, Maxwell Pistilli, Maureen G Maguire, Gui-Shuang Ying, Penny A Asbell; Exploratory Outcome Measures of the DRy Eye Assessment and Management (DREAM) Study. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5208.
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Previously reported results of the DREAM Study showed no difference in the primary outcome measure (Ocular Surface Disease Index) or secondary outcomes (signs, use of other treatments, quality of life, adverse events) between patients randomized to oral omega-3 (ω-3) supplementation or placebo in a 2:1 ratio. We report results of the effect of ω-3 supplementation relative to placebo on exploratory, minimally invasive objective outcome measures, including tear osmolarity, keratography measurements (non-invasive keratograph tear break-up-time (NIKBUT), bulbar redness, tear meniscus height, & upper/lower lid meibography) and matrix metalloproteinase (MMP)-9 positivity rates.
The DREAM study was a randomized, multi-center, double-masked, placebo controlled clinical trial conducted from November 2014 to July 2017. Patients with moderate to severe dry eye disease (DED) were assigned ω-3 (3000 mg) or placebo (5000 mg refined olive oil) supplements for 12 months. Exploratory outcomes of the DREAM study were measured on all (n=535) or a subset of patients. Tear osmolarity and keratography were measured at baseline, 6 months, and 12 months. MMP-9 positivity rates were measured at baseline and 3 months.
Changes from baseline to 12 months were similar (p≥0.21) between eyes of patients assigned to ω-3 supplements and patients assigned to placebo for NIKBUT, bulbar redness, tear meniscus height, and upper/lower lid meibography (see Table). Placebo and ω-3 groups had similar proportions positive for MMP-9 at 3 months (31% vs. 28%), p=0.69). Mean change (± standard deviation) in tear osmolarity at 12 months was -0.7 (± 21.5) in the ω-3 group and +3.6 (± 18.3) in the placebo group (p=0.02). However, the mean tear osmolarity values at 12 months were similar in placebo (303.3 ± 17.5) and ω-3 groups (303.1 ± 18.4, p=0.90).
Consistent with the DREAM primary and secondary outcome measures based on symptoms and classic signs of DED, there was no difference between the ω-3 and placebo groups on the objective measures of NIKBUT, bulbar redness, tear meniscus height, upper/lower lid meibography, and MMP-9 positivity. The clinical impact of the significant albeit small improvement in tear osmolarity (3.6 mOSmL) from baseline in the ω-3 group, but similar levels at 12 months in both treatment groups, is not clear.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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