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This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocular hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.03% Bimatoprost/0.5% Timolol in Same Bottle | Experimental | Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution |
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| 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | Active Comparator | Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution | Drug | One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section. | 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 |
|---|---|---|---|---|---|---|
| Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24571886 | Background | Ling Z, Zhang M, Hu Y, Yin Z, Xing Y, Fang A, Ye J, Chen X, Liu D, Wang Y, Sun W, Dong Y, Sun X. Safety and efficacy of bimatoprost/timolol fixed combination in Chinese patients with open-angle glaucoma or ocular hypertension. Chin Med J (Engl). 2014;127(5):905-10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution |
| FG001 | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution | Drug | One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution |
|
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Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution |
| BG001 | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution |
| BG002 | Total | Total of all reporting groups |
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Difference of Change From Baseline of Mean Diurnal Intraocular Pressure (IOP) Between the Two Treatment Groups at Week 4 | The difference of change from baseline of mean diurnal IOP between the 0.03% Bimatoprost/0.5% Timolol in Same Bottle and the 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles at week 4. IOP is a measurement of the fluid pressure inside the eye. Mean diurnal IOP is the average of the IOP values of the study eye (the eye with the highest IOP at baseline) over the 3 time points measured at 8AM, 12PM and 4PM. A negative number change from baseline indicated a reduction (improvement) in IOP. The difference of change from baseline in IOP is presented in the statistical analysis section. | Intent to Treatment population defined as all patients randomized. One patient in the 0.03% Bimatoprost/0.5% Timolol in Same Bottle group was not included in the analysis. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline, Week 4 |
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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 | 0.03% Bimatoprost/0.5% Timolol in Same Bottle | Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution | 0 | 121 | 30 | 121 | ||
| EG001 | 0.03% Bimatoprost and 0.5% Timolol in Separate Bottles | Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution | 2 | 114 | 29 | 114 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Goitre | Endocrine disorders | MedDRA (13.0) | Systematic Assessment |
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| Ocular hypertension | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hyperaemia | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (13.0) | Non-systematic Assessment |
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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 90 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 | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc. | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Male |
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