Dry Eye Assessment and Management (DREAM©) Study: Study design and baseline characteristics

Abstract

PurposeDescribe trial design and baseline characteristics of participants in the DRy Eye Assessment and Management (DREAM©) Study. DesignProspective, multi-center, randomized, double-masked “real-world” clinical trial assessing efficacy and safety of oral omega-3 (ω3) supplementation for the treatment of dry eye disease (DED). Methods•Setting: Multi-center study (27 sites) consisting of academic and private practices led by ophthalmologists and optometrists throughout the United States.•Study Population: 535 subjects with symptoms and signs of moderate to severe DED were randomized in a 2:1 ratio to ω3 or placebo. All participants, clinical staff, and laboratory personnel were masked to treatment assignment.•Intervention: 3000 mg ω3 (2000 mg eicosapentaenoic acid(EPA) and 1000 mg docosahexaenoic acid(DHA)) per day or placebo (5000 mg olive oil per day)•Primary Outcome: Change in dry eye symptoms (change from baseline to follow-up in the Ocular Surface Disease Index(OSDI) score). ResultsMean age of participants was 58.0 ± 13.2 years. Mean OSDI score at baseline was 44.4 ± 14.2. Mean conjunctival staining score (scale 0–6) was 3.0 ± 1.4, corneal staining score (scale 0–15) was 3.9 ± 2.7, tear break-up time was 3.1 ± 1.5 s, and Schirmer test was 9.6 ± 6.5 mm/5 min. ConclusionsDREAM© participants mirror real world patients who seek intervention for their DED-related symptoms despite their current treatments. Results regarding the efficacy of omega-3 supplementation will be helpful to clinicians and patients with moderate to severe DED who are considering omega-3 as a treatment. This trial design may be a model for future RCT's on nutritional supplements and DED treatments seeking to provide useful information for clinical practice. Trial registrationClinicalTrials.gov number NCT02128763.