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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-024513-31 | EudraCT Number |
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The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.
This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 2 study drug groups: Brinz/Brim or Brinz+Brim.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brinz/Brim | Experimental | Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. |
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| Brinz+Brim | Active Comparator | Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension | Drug |
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| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal IOP Change From Baseline at Month 3 | Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Baseline (Day 1), Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve Burmaster, PhD | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25430900 | Derived | Gandolfi SA, Lim J, Sanseau AC, Parra Restrepo JC, Hamacher T. Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension. Adv Ther. 2014 Dec;31(12):1213-27. doi: 10.1007/s12325-014-0168-y. Epub 2014 Nov 28. |
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Of the 1184 enrolled, 294 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. Of the 890 randomized, 2 subjects did not receive study medication. This reporting group includes all randomized subjects who received study medication (888), as treated.
Subjects were recruited from 102 investigational centers in the Asia-Pacific region, Canada, Central and South America, Europe, and the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brinz/Brim | Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
Inactive ingredients used as a placebo for masking purposes |
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| Brinzolamide 1% ophthalmic suspension | Drug |
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| Brimonidine tartrate 0.2% ophthalmic solution | Drug |
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| Brinz+Brim |
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. |
| COMPLETED |
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| NOT COMPLETED |
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This reporting group includes all subjects who received study medication, as treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brinz/Brim | Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. |
| BG001 | Brinz+Brim | Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. |
| 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 | |||||||||||||
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| 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 | |||||||||||||||||||||||
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| Primary | Mean Diurnal IOP Change From Baseline at Month 3 | Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). | Per Protocol (PP): All subjects who received study medication, satisfied prerandomization inclusion/exclusion criteria, and completed at least 1 scheduled on-therapy study visit. In addition, individual subject visits and data points that did not satisfy the protocol criteria may have been excluded. | Posted | Least Squares Mean | Standard Error | millimeters of mercury (mmHg) | Baseline (Day 1), Month 3 |
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Adverse events (AE) were collected for the duration of the study (1 year, 8 months). An AE was defined as any untoward medical occurrence in a subject that was administered a study medication, regardless of causal relationship with the medication.
This reporting group includes all subjects who received study medication, as treated. Reports of AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
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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 | Brinz/Brim | Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. | 11 | 452 | 0 | 452 | ||
| EG001 | Brinz+Brim | Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months. | 8 | 436 | 0 | 436 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal erosion | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Aortic valve incompetence | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Arthroscopy | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Finger amputation | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Kidney infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Mastectomy | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
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| Prostatic specific antigen increased | Investigations | MedDRA (13.0) | Systematic Assessment |
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| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA (13.0) | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
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| Pneumonia primary atypical | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
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| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
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| Venous occlusion | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
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| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Walker, PhD, Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D000068438 | Brimonidine Tartrate |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 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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| Male |
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