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

Phase 3CompletedNCT02089113

Ocular Therapeutix, Inc.241 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

241

Conditions

Post-Surgical Ocular Pain Post-Surgical Ocular Inflammation

Interventions

DexamethasoneDRUG

Placebo VehiclePROCEDURE

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 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

Outcomes

Primary Outcomes

Number of Participants With an Absence of Anterior Chamber Inflammation

Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14

Time frame: Day 14

Number of Participants With an Absence of Ocular Pain

Absence of pain (i.e., score of '0') in the study eye at Day 8

Time frame: Day 8

Data from ClinicalTrials.gov

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