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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combigan® | Active Comparator | 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® | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution | Drug | 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indianapolis | Indiana | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22246943 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1: Combigan® or Cosopt® |
|
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| fixed combination of dorzolamide hydrochloride timolol maleate ophthalmic solution | Drug | 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks |
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| 1 Month |
| 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 |
| 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 |
| 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 |
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Period 2: Wash Out |
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| Treatment Period 3: Combigan® or Cosopt® |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | All patients in the study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| ||||||||||||||||||||||||||||
| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| |||||||||||||||||||||||||||||
| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| 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). | Intent-to-treat population, which consisted of all patients that started the study (randomized) | Posted | Mean | Standard Deviation | Centimeters per second (cm/s) | 1 Month |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 15 | 0 | 15 | ||
| EG001 | 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. | 0 | 15 | 0 | 15 |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Medical Affairs | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013999 | Timolol |
| D009883 | Ophthalmic Solutions |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| C479140 | dorzolamide-timolol combination |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D000068438 | Brimonidine Tartrate |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
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