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

Condition(s) targeted: Glaucoma

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

Phase: Phase 4

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery

Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery

Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery

Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery

Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery

Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery

Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery

Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Indianapolis, Indiana, United States

Starting date: December 2008
Last updated: July 25, 2012