At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 258 enrolled
Drug / intervention
OTX-101 0.09%drug
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.
An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled 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 0.09% for Keratoconjunctivitis Sicca. Completed, enrolled 258 participants.
Detailed Summary
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKeratoconjunctivitis Sicca
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 2016
Enrollment StartJul 2016
Primary CompletionAug 2017
TodayJul 2026
First PostedJul 27, 2016
Enrollment StartJul 29, 2016
Primary CompletionAug 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 9.9 years ago
Interventions
OTX-101 0.09%drug
0.09% cyclosporine nanomicellar solution