At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 455 enrolled
Drug / intervention
OTX-101 0.05% +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 Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
In Brief
A Phase 3 clinical trial evaluating OTX-101 0.05%, OTX-101 0.09%, and 1 other intervention for Keratoconjunctivitis Sicca and Dry Eye Disease. Completed, enrolled 455 participants across 1 site.
Detailed Summary
This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca, Dry Eye Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartSep 2014
First PostedOct 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedOct 1, 2014
Enrollment StartSep 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.8 years ago
Interventions
OTX-101 0.05%drug
OTX-101 0.05% Ophthalmic Solution
OTX-101 0.09%drug
OTX-101 0.09% Ophthalmic Solution
Vehicledrug
Vehicle of OTX-101 Ophthalmic Solution