Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
- Registration Number
- NCT00520260
- Lead Sponsor
- Florida Eye Microsurgical Institute
- Brief Summary
To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Must be in general good health
- Diagnosis of moderate to severe dry eye syndrome
Exclusion Criteria
- Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
- Patients who are pregnant or nursing females
- Unwilling to discontinue use of contact lenses during the run-in and duration of the study
- Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
- Previous treatment failure on CSA 0.05% (Restasis)
- Known hypersensitivity to any component of the study or procedural medications
- Participation in any other clinical trial within 30 days prior to screening
- Known contraindication to any study medication or any of their components.
- Should not be taking any oral anti-histamines, beta blockers or diuretics.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 bromfenac Active treatment arm bromfenac 0.09% BID for 6 weeks 2 ketorolac ketorolac 0.4% BID for 6 weeks
- Primary Outcome Measures
Name Time Method Ocular comfort six weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Florida Eye Microsurgical Institute
🇺🇸Boynton Beach, Florida, United States