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

Sponsors

Lead Sponsor: Allergan

Source Allergan
Brief Summary

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.

Overall Status Completed
Start Date 2008-12-01
Completion Date 2009-12-01
Primary Completion Date 2009-12-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery 1 Month
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery 1 Month
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery 1 Month
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery 1 Month
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery 1 Month
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery 1 Month
Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery 1 Month
Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery 1 Month
Enrollment 15
Condition
Intervention

Intervention Type: Drug

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

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

Arm Group Label: Combigan®

Other Name: Combigan®

Intervention Type: Drug

Intervention Name: fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution

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

Arm Group Label: Cosopt®

Other Name: Cosopt®

Eligibility

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.

Gender:

All

Minimum Age:

30 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Medical Director Study Director Allergan
Location
Facility:
Location Countries

United States

Verification Date

2019-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Combigan®

Type: Active Comparator

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.

Label: Cosopt®

Type: Active Comparator

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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Investigator, Outcomes Assessor)

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