At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
OTX-DP (Dexamethasone punctum plug) +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 II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
In Brief
A Phase 2 clinical trial evaluating OTX-DP (Dexamethasone punctum plug) and Placebo Vehicle Punctum Plug for Ocular Inflammation and Pain. Completed, enrolled 60 participants across 1 site.
Detailed Summary
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOcular Inflammation and Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartOct 2012
Primary CompletionAug 2013
TodayJul 2026
First PostedAug 16, 2012
Enrollment StartOct 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.9 years ago
Interventions
OTX-DP (Dexamethasone punctum plug)drug
Sustained and tapered release of dexamethasone from hydrogel punctum plug
Placebo Vehicle Punctum Plugdrug
Hydrogel punctum plug without dexamethasone