DREAM (dry eye disease)
Trial question
What is the role of omega-3 fatty acid supplementation in patients with dry eye disease?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
81.0% female
19.0% male
N = 535
535 patients (434 female, 101 male).
Inclusion criteria: patients with moderate-to-severe dry eye disease.
Key exclusion criteria: worn contact lenses in the past 30 days; underwent laser-assisted in situ keratomileusis or recent ocular surgery; history of ocular infection; contraindications to treatment with high-dose omega-3 fatty acid supplementation.
Interventions
N=349 omega-3 supplements (daily oral dose of 3,000 mg of fish-derived omega-3 eicosapentaenoic and docosahexaenoic acids).
N=186 placebo (an olive oil matching placebo).
Primary outcome
Mean reduction in Ocular Surface Disease Index score
13.9 points
12.5 points
13.9 points
10.4 points
7.0 points
3.5 points
0.0 points
Omega-3
supplements
Placebo
No significant
difference ↔
No significant difference in mean reduction in Ocular Surface Disease Index score (13.9 points vs. 12.5 points; MD 1.9, 95% CI -1.1 to 5).
Secondary outcomes
No significant difference in mean reduction in conjunctival staining score (0.4 points vs. 0.4 points).
No significant difference in mean reduction in corneal staining score (0.6 points vs. 0.7 points; MD -0.1, 95% CI -0.4 to 0.2).
No significant difference in mean improvement in tear break-up time (0.7 seconds vs. 0.6 seconds; MD 0.2, 95% CI -0.1 to 0.5).
Safety outcomes
No significant difference in adverse events.
Conclusion
In patients with moderate-to-severe dry eye disease, omega-3 supplements were not superior to placebo with respect to mean reduction in Ocular Surface Disease Index score.
Reference
Dry Eye Assessment and Management Study Research Group, Penny A Asbell, Maureen G Maguire et al. n-3 Fatty Acid Supplementation for the Treatment of Dry Eye Disease. N Engl J Med. 2018 May 3;378(18):1681-1690.
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