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

Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00811850
• Other study ID #: GMA-COM-08-009
• Status: Completed
• Phase: Phase 4
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

Siesky B, Harris A, Ehrlich R, Cantor L, Shoja MM, Rusia D, Hollander DA, Abrams L, Williams JM, Shoshani Y. Short-term effects of brimonidine/timolol and dorzolamide/timolol on ocular perfusion pressure and blood flow in glaucoma. Adv Ther. 2012 Jan;29(1):53-63. doi: 10.1007/s12325-011-0092-3. Epub 2012 Jan 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery	Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).	1 Month
Primary	Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery	End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the nasal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).	1 Month
Primary	Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery	Peak systolic velocity (PSV) of retrobulbar blood as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in the blood vessel).	1 Month
Primary	Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery	End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the temporal short posterior ciliary artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).	1 Month
Primary	Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery	Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).	1 Month
Primary	Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery	End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the ophthalmic artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).	1 Month
Primary	Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery	Peak systolic velocity (PSV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. PSV is the maximum blood flow speed within a vessel at the time of systole (maximum pressure exerted in a blood vessel).	1 Month
Primary	Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery	End diastolic velocity (EDV) of retrobulbar blood flow as measured by color Doppler imaging (CDI) in the central retinal artery after 1 month of treatment. CDI is a high-resolution ultrasound system which provides visualization of the flow of blood through a vessel. EDV is the maximum blood flow speed within a vessel at the end of diastole (minimum pressure exerted in a blood vessel in between heart beats).	1 Month