At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 438 enrolled
Drug / intervention
Dexamethasone +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 Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
In Brief
A Phase 3 clinical trial evaluating Dexamethasone and Placebo Vehicle for Post-Surgical Ocular Pain and Post-Surgical Ocular Inflammation. Completed, enrolled 438 participants.
Detailed Summary
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedApr 2016
Primary CompletionMay 2016
Study CompletionJul 2016
TodayJul 2026
First PostedApr 13, 2016
Enrollment StartOct 1, 2015
Primary CompletionMay 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.2 years ago
Interventions
Dexamethasonedrug
Placebo Vehicleother