NCT02089113

OTX-14-003: 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 3B 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: 241 (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

• Post-Surgical Ocular Pain
• Post-Surgical Ocular Inflammation

Interventions

Type	Name	Description
DRUG	Dexamethasone
PROCEDURE	Placebo Vehicle

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-01-01
• Completion: 2015-03-01
• First posted: 2014-03-17
• Last updated: 2019-09-26
• Results posted: 2016-03-30