At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 91 enrolled
Drug / intervention
Low Dose 0.155µg/mL SkQ1 ophthalmic solution +2 moredrug
Likely dose
Low Dose 0.155µg/mL SkQ1 ophthalmic solutionfrom 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.
Phase 2, Single-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of SkQ1 Ophth Sol'n in the Environment and During Challenge in the Controlled Adverse Environment (CAE) Model for the Treatment of DES
In Brief
A Phase 2 clinical trial evaluating Low Dose 0.155µg/mL SkQ1 ophthalmic solution, High Dose 1.55µg/mL SkQ1 ophthalmic solution, and 1 other intervention for Keratoconjunctivitis Sicca. Completed, enrolled 91 participants across 1 site.
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--
ConditionsKeratoconjunctivitis Sicca
CountriesUnited States
CollaboratorsORA, Inc.
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionJun 2014
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartApr 1, 2014
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 12.2 years ago
Interventions
Low Dose 0.155µg/mL SkQ1 ophthalmic solutiondrug
eyedrops
High Dose 1.55µg/mL SkQ1 ophthalmic solutiondrug
eyedrops
Placebo (Vehicle) opthalmic solutiondrug
eyedrops