Comparing Effects of Two Fixed Combinations Ophthalmic Solutions on Ocular Blood Flow
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: 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. |
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
Other Names:
|
Active Comparator: 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. |
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery [1 Month]
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).
- Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery [1 Month]
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).
- Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery [1 Month]
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).
- Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery [1 Month]
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).
- Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery [1 Month]
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).
- Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery [1 Month]
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).
- Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery [1 Month]
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).
- Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery [1 Month]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age: 30 years or older.
-
Primary open-angle glaucoma (POAG) or ocular hypertensive in at least one eye.
-
Best corrected visual acuity at least 20/40 in at least one eye.
Exclusion Criteria:
-
History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
-
History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
-
History or signs of intraocular trauma.
-
Any abnormality preventing reliable applanation tonometry.
-
Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
-
Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Indianapolis | Indiana | United States |
Sponsors and Collaborators
- Allergan
Investigators
- Study Director: Medical Director, Allergan
Study Documents (Full-Text)
None provided.More Information
Publications
- GMA-COM-08-009
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | All Patients |
---|---|
Arm/Group Description | This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1). |
Period Title: Treatment Period 1: Combigan® or Cosopt® | |
STARTED | 15 |
COMPLETED | 15 |
NOT COMPLETED | 0 |
Period Title: Treatment Period 1: Combigan® or Cosopt® | |
STARTED | 15 |
COMPLETED | 15 |
NOT COMPLETED | 0 |
Period Title: Treatment Period 1: Combigan® or Cosopt® | |
STARTED | 15 |
COMPLETED | 15 |
NOT COMPLETED | 0 |
Baseline Characteristics
Arm/Group Title | All Patients |
---|---|
Arm/Group Description | All patients in the study |
Overall Participants | 15 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
68.1
(NA)
|
Sex: Female, Male (Count of Participants) | |
Female |
8
53.3%
|
Male |
7
46.7%
|
Outcome Measures
Title | Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
8.61
(2.33)
|
8.02
(2.51)
|
Title | Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Nasal Short Posterior Ciliary Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
2.63
(0.71)
|
2.61
(0.63)
|
Title | Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
8.52
(1.57)
|
8.84
(1.75)
|
Title | Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Temporal Short Posterior Ciliary Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
2.73
(0.67)
|
2.87
(0.95)
|
Title | Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
24.5
(11.25)
|
22.09
(8.25)
|
Title | Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Ophthalmic Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
5.83
(2.49)
|
5.18
(2.33)
|
Title | Retrobulbar Blood Flow (Peak Systolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
8.86
(2.19)
|
8.81
(2.54)
|
Title | Retrobulbar Blood Flow (End Diastolic Velocity) as Measured by Color Doppler Imaging in the Central Retinal Artery |
---|---|
Description | 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). |
Time Frame | 1 Month |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat population, which consisted of all patients that started the study (randomized) |
Arm/Group Title | Combigan® | Cosopt® |
---|---|---|
Arm/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. | 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. |
Measure Participants | 15 | 15 |
Mean (Standard Deviation) [Centimeters per second (cm/s)] |
2.73
(0.65)
|
2.75
(0.78)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Combigan® | Cosopt® | ||
Arm/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. | 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. | ||
All Cause Mortality |
||||
Combigan® | Cosopt® | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Combigan® | Cosopt® | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Combigan® | Cosopt® | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/15 (0%) | 0/15 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 30 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo
Results Point of Contact
Name/Title | Vice President, Medical Affairs |
---|---|
Organization | Allergan, Inc. |
Phone | 714-246-4500 |
clinicaltrials@allergan.com |
- GMA-COM-08-009