A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Phase 3
Completed
- Conditions
- Dry Eye Syndrome
- Interventions
- Registration Number
- NCT01212471
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 840
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bromfenac Ophthalmic Solution A Bromfenac Ophthalmic Solution A Bromfenac ophthalmic solution A Bromfenac Ophthalmic Solution B Bromfenac Ophthalmic Solution B Bromfenac ophthalmic solution B Placebo Comparator Placebo Comparator Placebo Comparator
- Primary Outcome Measures
Name Time Method Mean Ocular Surface Disease Index (OSDI) Total Score 42 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
ISTA Pharmaceuticals, Inc.
🇺🇸Irvine, California, United States