At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 180 enrolled
Drug / intervention
OmegaD +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 OmegaD and Placebo for Dry Eye. Completed, enrolled 180 participants across 11 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 dosed orally BID for 84 days. Approximately 164 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
2017201820192020202120222023202420252026
Enrollment StartOct 2016
First PostedDec 2016
Primary CompletionFeb 2017
TodayJul 2026
First PostedDec 2, 2016
Enrollment StartOct 1, 2016
Primary CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.6 years ago
Interventions
OmegaDdrug
OmegaD Softgels
Placebodrug
Placebo Softgels