Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
Information source: Florida Eye Microsurgical Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dry Eye Disease; Ocular Comfort
Intervention: bromfenac (Drug); ketorolac (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Florida Eye Microsurgical Institute Official(s) and/or principal investigator(s): Barry Schechter, MD, Principal Investigator, Affiliation: Florida Eye Microsurgical Institute
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
Clinical Details
Official title: Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Ocular comfort
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Florida Eye Microsurgical Institute, Boynton Beach, Florida 33426, United States
Additional Information
Starting date: August 2007
Last updated: February 17, 2009
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