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This is a safety and efficacy study of fixed-combination bimatoprost and brimonidine compared with LUMIGAN® and ALPHAGAN® in patients with chronic glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | Experimental | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
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| Bimatoprost Ophthalmic Solution 0.01% and Vehicle | Active Comparator | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
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| Brimonidine Tartrate Ophthalmic Solution 0.2% | Active Comparator | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed-Combination Bimatoprost/Brimonidine | Drug | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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, Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average Eye Mean Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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). |
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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 |
|---|---|---|---|---|---|---|
| Newport Beach | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fixed-Combination Bimatoprost/Brimonidine | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
| FG001 | Bimatoprost Ophthalmic Solution 0.01% and Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bimatoprost Ophthalmic Solution 0.01% | Drug | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks. |
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| Vehicle Ophthalmic Solution | Drug | One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
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| Brimonidine Tartrate Ophthalmic Solution 0.2% | Drug | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
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| Baseline, Day 14, Day 28 |
| Average Eye Mean Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. | Day 14, Day 28, Day 42 |
One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
| FG002 | Brimonidine Tartrate Ophthalmic Solution 0.2% | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fixed-Combination Bimatoprost/Brimonidine | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. |
| BG001 | Bimatoprost Ophthalmic Solution 0.01% and Vehicle | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. |
| BG002 | Brimonidine Tartrate Ophthalmic Solution 0.2% | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. |
| BG003 | 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, Customized | Number | Participants |
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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 | Change From Baseline in Average Eye Mean Diurnal Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Day 42 |
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| Secondary | Change From Baseline in Average Eye Mean Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. 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: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 14, Day 28 |
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| Secondary | Average Eye Mean Diurnal IOP | IOP is a measurement of the fluid pressure inside the eye. Average eye mean diurnal IOP is the mean of the average eye IOPs (average IOP of the right and left eyes) at hours 0, 2, 4, 8 and 12. | Modified Intent to Treat: all randomized and treated patients who had baseline and at least 1 postbaseline IOP assessment | Posted | Mean | Standard Deviation | mmHg | Day 14, Day 28, Day 42 |
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Treatment emergent adverse events (TEAE) are reported and include all adverse events (AEs) and serious adverse events (SAEs) that began or worsened after study treatment.
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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 | Fixed-Combination Bimatoprost/Brimonidine | One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks. | 0 | 38 | 27 | 38 | ||
| EG001 | Bimatoprost Ophthalmic Solution 0.01% and Vehicle | One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks. | 1 | 36 | 25 | 36 | ||
| EG002 | Brimonidine Tartrate Ophthalmic Solution 0.2% | One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks. | 1 | 38 | 20 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.1 | Systematic Assessment |
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| Acute Myocardial Infarction | Cardiac disorders | MedDRA version 16.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
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| Eye Pruritus | Eye disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Eye Discharge | Eye disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Blepharospasm | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
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| Punctate Keratitis | Eye disorders | MedDRA version 16.1 | Systematic Assessment |
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| Eye Pain | Eye disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Instillation Site Pruritus | General disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Foreign Body Sensation in Eyes | Eye disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Instillation Site Lacrimation | General disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Vision Blurred | Eye disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Eye Irritation | Eye disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 16.1 | Non-systematic Assessment |
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| Dry Mouth | Gastrointestinal disorders | MedDRA version 16.1 | Non-systematic Assessment |
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| Spinal Column Stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 16.1 | 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 |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D000069580 | Bimatoprost |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Between 45 and 65 years |
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| >65 years |
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| Male |
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| Participants |
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| Participants |
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