At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 452 enrolled
Drug / intervention
Low Dose - SkQ1 +2 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 Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophthalmic Solution for the Treatment of Dry Eye Syndrome
In Brief
A Phase 3 clinical trial evaluating Low Dose - SkQ1, High dose - SkQ1, and 1 other intervention for Dry Eye Syndrome. Completed, enrolled 452 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate whether SkQ1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
CollaboratorsORA, Inc.
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartDec 2018
Primary CompletionFeb 2019
TodayJul 2026
First PostedDec 5, 2018
Enrollment StartDec 6, 2018
Primary CompletionFeb 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.6 years ago
Interventions
Low Dose - SkQ1drug
SkQ1 Low dose ophthalmic solution
High dose - SkQ1drug
SkQ1 High Dose ophthalmic solution
SkQ1 (Vehicle)drug
Vehicle for SkQ1 ophthalmic solution