At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 322 enrolled
Drug / intervention
Omega 3 fatty acid +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Double-Masked, Placebo Controlled Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
In Brief
A Phase 3 clinical trial evaluating Omega 3 fatty acid and Placebos for Dry Eye. Completed, enrolled 322 participants across 14 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartNov 2019
First PostedNov 2019
Primary CompletionFeb 2021
TodayJul 2026
First PostedNov 29, 2019
Enrollment StartNov 18, 2019
Primary CompletionFeb 28, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.6 years ago
Interventions
Omega 3 fatty aciddrug
Omega 3 fatty acid Softgels
Placebosdrug
Mineral oil Softgels