At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 610 enrolled
Drug / intervention
SkQ1 Vehicle Solution +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 Phase 3, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Study of Safety and Efficacy of SkQ1 Ophthalmic Solution in the Environment and the Controlled Adverse Environmental (CAE®) Model for the Treatment of Dry Eye Syndrome
In Brief
A Phase 3 clinical trial evaluating SkQ1 Vehicle Solution and SkQ1 Ophthalmic Solution for Dry Eye Syndrome. Completed, enrolled 610 participants across 4 sites.
Detailed Summary
The purpose of this study is to evaluate whether SkQ1 Ophthalmic Solution is safe and effective compared to Vehicle 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
2020202120222023202420252026
First PostedDec 2019
Enrollment StartDec 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedDec 20, 2019
Enrollment StartDec 20, 2019
Primary CompletionOct 6, 2020
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 6.5 years ago
Interventions
SkQ1 Vehicle Solutiondrug
SkQ1 Ophthalmic Solution Vehicle
SkQ1 Ophthalmic Solutiondrug
SkQ1 Ophthalmic Solution