Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Florida Eye Microsurgical Institute

Status and phase: Completed; Phase 4

Conditions: Dry Eye Disease; Ocular Comfort

Treatments: Drug: bromfenac; Drug: ketorolac

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00520260

Sch012007

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

1

Active Comparator group

Description:

Active treatment arm bromfenac 0.09% BID for 6 weeks

Treatment:

Drug: bromfenac

2

Active Comparator group

Description:

ketorolac 0.4% BID for 6 weeks

Treatment:

Drug: ketorolac