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This study will evaluate the safety and efficacy of brimonidine tartrate/timolol fixed combination (Combigan®) compared with brimonidine tartrate (Alphagan®) and timolol in patients with glaucoma or ocular hypertension who do not respond well to topical beta blockers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combigan® | Other | One drop of brimonidine tartrate/timolol combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
|
| Alphagan® and Timolol Concurrent | Active Comparator | One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brimonidine tartrate/timolol fixed combination ophthalmic solution | Drug | One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). | Baseline, Week 4 |
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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 |
|---|---|---|---|---|---|---|
| Guangzhou | Guangdong | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combigan® | One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
| FG001 | Alphagan® and Timolol Concurrent |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| brimonidine tartrate ophthalmic solution | Drug | One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
|
|
| timolol ophthalmic solution | Drug | One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
|
| fixed combination vehicle | Other | Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
|
One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Combigan® | One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
| BG001 | Alphagan® and Timolol Concurrent | One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye at Week 4 | Intraocular pressure (IOP) was measured in the study eye at baseline and Week 4. IOP is a measurement of the fluid pressure inside the eye. A negative number change from baseline indicates a reduction in IOP (improvement). | Intent-to-treat population consisted of all randomized participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline, Week 4 |
|
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Safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
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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® | One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks. | 1 | 120 | 0 | 120 | ||
| EG001 | Alphagan® and Timolol Concurrent | One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks. | 1 | 116 | 0 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| VIth nerve paralysis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D000068599 | Brimonidine Tartrate, Timolol Maleate Drug Combination |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013999 | Timolol |
| 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 |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Male |
|