At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 241 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 3B 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 241 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
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionJan 2015
Study CompletionMar 2015
TodayJul 2026
First PostedMar 17, 2014
Enrollment StartApr 1, 2014
Primary CompletionJan 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 12.3 years ago
Interventions
Dexamethasonedrug
Placebo Vehicleprocedure