Trials / Completed
CompletedNCT04050865
A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
CLN-0052, A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluation the Efficacy and Safety of OTX-DP for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 96 (actual)
- Sponsor
- Ocular Therapeutix, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dexamethasone, 0.4mg | Ophthalmic Insert |
| DEVICE | Placebo plug with no drug | Ophthalmic Insert |
Timeline
- Start date
- 2019-08-05
- Primary completion
- 2020-02-28
- Completion
- 2020-02-28
- First posted
- 2019-08-08
- Last updated
- 2021-10-07
- Results posted
- 2021-10-07
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04050865. Inclusion in this directory is not an endorsement.