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This study will evaluate the safety and efficacy of bimatoprost 0.03% formulation B ophthalmic solution with LUMIGAN® (bimatoprost ophthalmic solution 0.03%) once daily for 12 weeks in patients with glaucoma or ocular hypertension
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Experimental | Bimatoprost 0.03% Formulation B Ophthalmic Solution |
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| Bimatoprost 0.03% Ophthalmic Solution | Active Comparator | Bimatoprost 0.03% Ophthalmic Solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimatoprost 0.03% Formulation B Ophthalmic Solution | Drug | One drop administered in each eye, every evening, for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. | Baseline, Week 12 |
| Average Eye IOP at Week 12 | Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. | Baseline, Week 12 |
| Average Eye IOP at Week 6 | Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. | Week 6 |
| Average Eye IOP at Week 2 | Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. | Week 2 |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23743437 | Background | Day DG, Walters TR, Schwartz GF, Mundorf TK, Liu C, Schiffman RM, Bejanian M. Bimatoprost 0.03% preservative-free ophthalmic solution versus bimatoprost 0.03% ophthalmic solution (Lumigan) for glaucoma or ocular hypertension: a 12-week, randomised, double-masked trial. Br J Ophthalmol. 2013 Aug;97(8):989-93. doi: 10.1136/bjophthalmol-2012-303040. Epub 2013 Jun 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Formulation B Ophthalmic Solution |
| FG001 | Bimatoprost 0.03% Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Bimatoprost 0.03% Ophthalmic Solution | Drug | One drop administered in each eye, every evening, for 12 weeks |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Formulation B Ophthalmic Solution |
| BG001 | Bimatoprost 0.03% Ophthalmic Solution | Bimatoprost 0.03% 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, 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 Worse Eye Intraocular Pressure (IOP) at Week 12 | Change from baseline in worse eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements in the worse eye were evaluated at hours 0, 2, and 8. A negative number change from baseline indicated a reduction in IOP, and a positive number change from baseline indicated an increase in IOP. | Per Protocol Population: All randomized patients who did not have a protocol violation that significantly affected the conduct or the results of the trial. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 12 |
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| Primary | Average Eye IOP at Week 12 | Average Eye IOP at Week 12 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. Baseline data are included for reference only. | Intent to Treat Population: all randomized patients. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Baseline, Week 12 |
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| Primary | Average Eye IOP at Week 6 | Average Eye IOP at Week 6 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. | Intent to Treat Population: all randomized patients. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Week 6 |
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| Primary | Average Eye IOP at Week 2 | Average Eye IOP at Week 2 . IOP is a measurement of fluid pressure inside the eye. IOP measurements were evaluated at hours 0, 2, and 8 in both eyes and the average IOP of both eyes at each time point were reported. | Intent to Treat Population: all randomized patients. | Posted | Mean | Standard Deviation | Millimeters of Mercury (mmHg) | Week 2 |
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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 | Bimatoprost 0.03% Formulation B Ophthalmic Solution | Bimatoprost 0.03% Formulation B Ophthalmic Solution | 2 | 301 | 72 | 301 | ||
| EG001 | Bimatoprost 0.03% Ophthalmic Solution | Bimatoprost 0.03% Ophthalmic Solution | 5 | 295 | 77 | 295 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
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| Spinal Compression Fracture | Injury, poisoning and procedural complications | MedDRA version 14.0 | Systematic Assessment |
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| Atrial Fibrillation | Cardiac disorders | MedDRA version 14.0 | Systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA version 14.0 | Systematic Assessment |
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| Death | General disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Transitional Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival Hyperaemia | Eye disorders | MedDRA version 14.0 | 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 |
|---|---|
| D000069580 | Bimatoprost |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| 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 |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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| Title | Measurements |
|---|---|
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| >65 years |
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| Male |
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| Baseline Hour 8 |
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| Change from Baseline Hour 0 at Week 12 |
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| Change from Baseline Hour 2 at Week 12 |
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| Change from Baseline Hour 8 at Week 12 |
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