At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 153 enrolled
Drug / intervention
OTX-CSI +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, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)
In Brief
A Phase 2 clinical trial evaluating OTX-CSI and Placebo Vehicle for Dry Eye Disease. Completed, enrolled 153 participants across 15 sites.
Detailed Summary
To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
Enrollment StartApr 2020
First PostedApr 2020
Primary CompletionAug 2021
TodayJul 2026
First PostedApr 27, 2020
Enrollment StartApr 23, 2020
Primary CompletionAug 11, 2021
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 6.2 years ago
Interventions
OTX-CSIdrug
OTX-CSI intracanalicular insert
Placebo Vehicleother
Hydrogel Vehicle intracanalicular insert