A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease

Phase 3CompletedNCT01212471

Bausch & Lomb Incorporated840 enrolled

Overview

A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

840

Conditions

Dry Eye Syndrome

Interventions

Bromfenac Ophthalmic Solution ADRUG

sterile ophthalmic solution

Bromfenac Ophthalmic Solution BDRUG

sterile ophthalmic solution

Placebo ComparatorDRUG

sterile ophthalmic solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be of either gender and any race 18 years or older Exclusion Criteria: * Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Locations (1)

ISTA Pharmaceuticals, Inc.

Irvine, California, United States

Outcomes

Primary Outcomes

Mean Ocular Surface Disease Index (OSDI) Total Score

The Ocular Surface Disease Index (OSDI) is a 12 item questionnaire. Each question about discomfort/limitations is scored from 0 to 4, with 0 being 'None of the Time' and 4 being 'All of the Time'. The minimum total score is 0 and the maximum total score is 48, with higher scores indicating worse outcomes.

Time frame: 42 days

Data from ClinicalTrials.gov

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