A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

Phase 3 Completed 96 enrolled Ocular Therapeutix, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2019-08-05
Primary completion: 2020-02-28
Completion: 2020-02-28

Outcome

Met primary endpoint

paper Compared to PBO, there were statistically significant treatment differences favoring DEX for the primary endpoint of mean ocular itching score at Day 8 PMID 39328900 ↗

paper (-0.86, -0.98, -0.96 at 3, 5, and 7 minutes post-CAC respectively; P<0.0001 for all). PMID 39328900 ↗

Publications

Kenyon K, McLaurin EB, Silverstein SM, Meyer JC, Anderson E, Patel RH, Gomes PJ, Reilly E, Vantipalli S, Cheung MW, Goldstein MH. A Randomized, Multicenter Phase 3 Clinical Trial Evaluating Intracanalicular Dexamethasone Insert for the Treatment of Allergic Conjunctivitis. Clin Ophthalmol. 2024 Sep 21;18:2671-2684. doi: 10.2147/OPTH.S476419. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	0.4 mg	Other