Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
Overview
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
Full Title of Study: “Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: August 2008
Interventions
- Drug: bromfenac
- 0.09%, BID, 6 weeks
- Drug: ketorolac
- 0.4%, BID, 6 weeks
Arms, Groups and Cohorts
- Active Comparator: 1
- Active treatment arm bromfenac 0.09% BID for 6 weeks
- Active Comparator: 2
- ketorolac 0.4% BID for 6 weeks
Clinical Trial Outcome Measures
Primary Measures
- Ocular comfort
- Time Frame: six weeks
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Florida Eye Microsurgical Institute
- Collaborator
- Bausch & Lomb Incorporated
- Provider of Information About this Clinical Study
- Barry Schechter, MD, Florida Eye Microsurgical Institute
- Overall Official(s)
- Barry Schechter, MD, Principal Investigator, Florida Eye Microsurgical Institute
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