Trials / Completed
CompletedNCT01666210
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Ocular Therapeutix, Inc. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OTX-DP (Dexamethasone punctum plug) | Sustained and tapered release of dexamethasone from hydrogel punctum plug |
| DRUG | Placebo Vehicle Punctum Plug | Hydrogel punctum plug without dexamethasone |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-08-01
- Completion
- 2013-08-01
- First posted
- 2012-08-16
- Last updated
- 2021-10-19
- Results posted
- 2017-04-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01666210. Inclusion in this directory is not an endorsement.