Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Detailed Description

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Conditions

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Dry Eye Disease Ocular Comfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Active treatment arm bromfenac 0.09% BID for 6 weeks

Group Type ACTIVE_COMPARATOR

bromfenac

Intervention Type DRUG

0.09%, BID, 6 weeks

2

ketorolac 0.4% BID for 6 weeks

Group Type ACTIVE_COMPARATOR

ketorolac

Intervention Type DRUG

0.4%, BID, 6 weeks

Interventions

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bromfenac

0.09%, BID, 6 weeks

Intervention Type DRUG

ketorolac

0.4%, BID, 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No