A Randomized, Multicenter, Double-Masked, Placebo Controlled Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
Abstract
This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be compared to 2 placebo softgels (mineral oil ) dosed orally BID for 84 days. Approximately 300 subjects will be evaluated for their signs and symptoms of dry eye disease and for safety throughout the study.
Conditions: Dry Eye.
Primary outcome: Tear Osmolarity; Ocular Surface Disease Index (OSDI).
Enrollment: 322 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 322 participants or records.
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