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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005936-99 | EudraCT Number |
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The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZARGA/COMBIGAN | Other | AZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. |
|
| COMBIGAN/AZARGA | Other | COMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension | Drug | Fixed combination ophthalmic suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6 | Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Week 0, Week 6 (period-based) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6 | Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center at 1-888-451-3937 For Trial Locations | Fort Worth | Texas | 76134 | United States |
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Participants were recruited from and enrolled at one study center located in Greece.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZARGA/COMBIGAN | AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods. |
| FG001 | COMBIGAN/AZARGA | COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One: 6 Weeks |
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| Washout: 4 Weeks |
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| Period 2: 6 Weeks |
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This reporting group includes all enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | All enrolled |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6 | Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). | Posted | Mean | Standard Error | mmHg (millimeters of mercury) | Week 0, Week 6 (period-based) | eyes | Participants |
|
Adverse events were collected for the duration of the study.
The safety population is defined as patients who received study medication.
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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 | AZARGA | One drop in the study eye, twice daily (9:00 and 21:00), for six weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Recurrent Illness |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Global Medical Affairs | Alcon Research, Ltd. | 1-888-451-3937 |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D013999 | Timolol |
| C571752 | Azarga |
| D000068438 | Brimonidine Tartrate |
| D009883 | Ophthalmic Solutions |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution | Drug | Fixed combination ophthalmic solution |
|
|
| Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6 | Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6 | Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Diastolic Blood Pressure at Week 6 | Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Systolic Blood Pressure at Week 6 | Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6 | Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks | Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6 | End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6 | Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | Week 0, Week 6 (period-based) |
| Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6 | Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | Week 0, Week 6 (period-based) |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | COMBIGAN | One drop in the study eye, twice daily (9:00 and 21:00), for six weeks |
|
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| Secondary | Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6 | Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). | Posted | Mean | Standard Error | mmHg (millimeters of mercury) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| Secondary | Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6 | Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Mean | Standard Error | Arbitrary Units | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| Secondary | Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6 | Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Mean | Standard Error | Arbitrary Units | Week 0, Week 6 (period-based) | eyes | Participants |
|
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| Secondary | Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6 | Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). | Posted | Mean | Standard Error | mmHg (millimeters of mercury) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| Secondary | Mean Change From Baseline in Diastolic Blood Pressure at Week 6 | Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). | Posted | Mean | Standard Error | mmHg (millimeters of mercury) | Week 0, Week 6 (period-based) |
|
|
|
| Secondary | Mean Change From Baseline in Systolic Blood Pressure at Week 6 | Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). | Posted | Mean | Standard Error | mmHg (millimeters of mercury) | Week 0, Week 6 (period-based) |
|
|
|
| Secondary | Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6 | Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Mean | Standard Error | cm/s (centimeters per second) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
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| Secondary | Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks | Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Mean | Standard Error | cm/s (centimeters per second) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| Secondary | Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6 | End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Mean | Standard Error | cm/s (centimeters per second) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| Secondary | Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6 | Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Median | Standard Error | cm/s (centimeters per second) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| Secondary | Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6 | Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period. | This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received. | Posted | Mean | Standard Error | cm/s (centimeters per second) | Week 0, Week 6 (period-based) | eyes | Participants |
|
|
|
| 1 |
| 34 |
| 0 |
| 34 |
| EG001 | COMBIGAN | One drop in the study eye, twice daily (9:00 and 21:00), for six weeks | 0 | 34 | 0 | 34 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| 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 |
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D004338 | Drug Combinations |
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