Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Florida Eye Microsurgical Institute
• Collaborator: Bausch & Lomb Incorporated
• Treatments: Bromfenac; Cyclosporine; Cyclosporins; Ketorolac; Ketorolac Tromethamine

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.