Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery

Phase 3CompletedNCT00853970

Bausch & Lomb Incorporated299 enrolled

Overview

Efficacy study of Bromfenac Ophthalmic Solution in cataract surgery

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

299

Conditions

Pain Inflammation

Interventions

Bromfenac Ophthalmic SolutionDRUG

sterile ophthalmic solution

Placebo ComparatorDRUG

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

Summed Ocular Inflammation Score (SOIS) of Zero

Participants with SOIS of 0. Measured on a scale of 0-4: 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 (Primary Endpoint)

Secondary Outcomes

Pain Free

Participants that are pain free at day 1, taken from patient questionnaire with multiple possible responses measured on a scale of 0-3, where 0=none and 3=severe.

Time frame: Day 1

Data from ClinicalTrials.gov

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