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Clinical trial

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

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Last updated:1st Nov 2015

The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model
Estimated Enrollment: 72
Study Start Date: November 2015
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
OTX-DP treatment
- Placebo Comparator: Placebo Drug Delivery Vehicle

Category Value
Study start date 2015-11-01

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