Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Phase 3CompletedNCT00704418

Bausch & Lomb Incorporated156 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

Cataract

Interventions

BromfenacDRUG

sterile ophthalmic solution

PlaceboDRUG

sterile ophthalmic solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Scheduled for cataract surgery Exclusion Criteria: * Known hypersensitivity to bromfenac and salicylates

Locations (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Outcomes

Primary Outcomes

Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero

Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)

Time frame: Day 15

Secondary Outcomes

Number of Participants That Are Pain Free

Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses

Time frame: Day 1

Data from ClinicalTrials.gov

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