CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 745 enrolled
Drug / intervention
cyclosporine +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.

Search/NCT02688556
NCT02688556Phase 3Completed
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A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Sun Pharmaceutical Industries Limited·interventional·Posted Feb 23, 2016·Updated Aug 29, 2022

In Brief

A Phase 3 clinical trial evaluating cyclosporine and vehicle of OTX-101 for Keratoconjunctivitis Sicca. Completed, enrolled 745 participants across 3 sites.

Detailed Summary

This is a randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 23, 2016
Enrollment StartFeb 1, 2016
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.4 years ago

Interventions

cyclosporinedrug

vehicle of OTX-101drug