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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811850

GMA-COM-08-009

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

Combigan®

Active Comparator group

Description:

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.

Treatment:

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

Cosopt®

Active Comparator group

Description:

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.

Treatment:

Drug: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution