Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-12-31

Brief Summary

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A 10 week evaluation, crossover design study including a 3 week washout period between treatments, to determine the effects of Combigan® (fixed combination brimonidine tartrate 0.2%/timolol maleate 0.5%) and Cosopt® (fixed combination dorzolamide hydrochloride-timolol maleate ophthalmic solutions) on ocular blood flow as measured by retrobulbar blood flow.

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Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Combigan®

Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.

Group Type ACTIVE_COMPARATOR

fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution

Intervention Type DRUG

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Cosopt®

Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.

Group Type ACTIVE_COMPARATOR

fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution

Intervention Type DRUG

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Interventions

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fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Intervention Type DRUG

fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution

1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks

Intervention Type DRUG

Other Intervention Names

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Combigan® Cosopt®

Eligibility Criteria

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Inclusion Criteria

1. Age: 30 years or older.
2. Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
3. Best corrected visual acuity at least 20/40 in at least one eye.

Exclusion Criteria

1. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
2. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
3. History or signs of intraocular trauma.
4. Any abnormality preventing reliable applanation tonometry.
5. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
6. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No