Dry Eye Disease Clinical Trial
Official title:
Bromfenac 0.09% vs. Ketorolac 0.4% During the Induction Phase of Treatment With Topical Cyclosporine for Chronic Dry Eye Patients
Verified date | February 2009 |
Source | Florida Eye Microsurgical Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 42 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Florida Eye Microsurgical Institute | Boynton Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida Eye Microsurgical Institute | Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular comfort | six weeks |
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