Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Phase 3CompletedNCT00703781

Bausch & Lomb Incorporated126 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

126

Conditions

Cataract

Interventions

bromfenac ophthalmic solutionDRUG

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 (trace); 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 taken from patient questionnaire with multiple possible responses (None, Mild, Moderate, Severe) within one hour of instilling eye drop

Time frame: Day 1

Data from ClinicalTrials.gov

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