Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Phase 3CompletedNCT02034019

Ocular Therapeutix, Inc.247 enrolled

Overview

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 post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

247

Conditions

Post Ocular Surgical Inflammation and Pain

Interventions

DexamethasoneDRUG

Punctum PlugDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens * Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes Exclusion Criteria: * Any intraocular inflammation in the study eye present during the screening slit lamp examination * Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening * Any intraocular inflammation in the study eye present during the screening slit lamp examination

Locations (1)

Texan Eye / Keystone Research, Ltd.

Austin, Texas, United States

Outcomes

Primary Outcomes

Absence of Cells in Anterior Chamber of the Study Eye

Time frame: Day 14

Absence of Pain in Study Eye

Time frame: Day 8

Data from ClinicalTrials.gov

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