Trials / Completed
CompletedNCT02736175
OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 438 (actual)
- Sponsor
- Ocular Therapeutix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone | |
| OTHER | Placebo Vehicle |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2016-05-01
- Completion
- 2016-07-01
- First posted
- 2016-04-13
- Last updated
- 2017-11-13
- Results posted
- 2017-10-11
Source: ClinicalTrials.gov record NCT02736175. Inclusion in this directory is not an endorsement.