Efficacy of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Phase 3CompletedNCT01367249

Bausch & Lomb Incorporated440 enrolled

Overview

This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

440

Conditions

Pain Inflammation Cataract

Interventions

Bromfenac Ophthalmic SolutionDRUG

Sterile ophthalmic solution

PlaceboDRUG

Sterile ophthalmic solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female at least 18 years of age who are scheduled for unilateral cataract surgery Exclusion Criteria: * Have known hypersensitivity to bromfenac or to any component of the investigational product

Locations (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Outcomes

Primary Outcomes

Ocular Inflammation

The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.

Time frame: Day 15

Secondary Outcomes

Ocular Pain

The proportion of subjects who were free of ocular pain at Day 1. Pain Free defined as a score of "None" on the pain scale of the Ocular Comfort Grading Assessment in the subject diary.

Time frame: Day 1

Data from ClinicalTrials.gov

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