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This study will investigate the safety and efficacy of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) in patients with glaucoma or ocular hypertension who have elevated intraocular pressure (IOP) on brimonidine/timolol ophthalmic solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple Combination Therapy | Experimental | One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution | Drug | One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Diurnal Intraocular Pressure (IOP) in the Study Eye | IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). | Baseline, Week 12 |
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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 |
|---|---|---|---|---|---|---|
| Coimbatore | Tamil Nadu | India |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triple Combination Therapy | One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Triple Combination Therapy | One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the mean of the IOP values at hour 0, hour 2 and hour 8 at each visit in the study eye. A negative number change from baseline indicates a reduction in IOP (improvement), and a positive number change from baseline indicates an increase in IOP (worsening). | Modified Intent to Treat: includes all qualified patients with a baseline and at least 1 postbaseline efficacy evaluation | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 12 |
|
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The Safety Population was used for adverse events (AEs) and serious adverse events (SAEs) and included all qualified treated patients.
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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 | Triple Combination Therapy | One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 121 |
| 20 |
| 121 |
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.
| D011465 |
| Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |