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The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.
This study consisted of 6 visits conducted during 2 sequential phases: the Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brinzolamide/Brimonidine | Experimental | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months |
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| Brinzolamide | Active Comparator | Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months |
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| Brimonidine | Active Comparator | Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension | Drug |
| ||
| Brinzolamide ophthalmic suspension, 1% |
| Measure | Description | Time Frame |
|---|---|---|
| Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h) | At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). | Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Teague, BS, Sr. Clinical Manager | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23579344 | Derived | Katz G, Dubiner H, Samples J, Vold S, Sall K. Three-month randomized trial of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%. JAMA Ophthalmol. 2013 Jun;131(6):724-30. doi: 10.1001/jamaophthalmol.2013.188. |
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Of the 1001 enrolled, 341 subjects did not qualify for treatment and were exited without exposure to product. The 660 subjects eligible for treatment were randomized (1:1:1) to study drug. This reporting group includes all randomized subjects, as treated.
Subjects were recruited from 68 study centers in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brinzolamide/Brimonidine | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months |
| FG001 | Brinzolamide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| Brimonidine tartrate ophthalmic solution, 0.2% | Drug |
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Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
| FG002 | Brimonidine | Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months |
| COMPLETED |
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| NOT COMPLETED |
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This reporting group includes all participants randomized to study drug, as treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Brinzolamide/Brimonidine | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months |
| BG001 | Brinzolamide | Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months |
| BG002 | Brimonidine | Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months |
| 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 | Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h) | At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). | Intent-to-treat (ITT): All patients who received study medication and completed at least 1 scheduled on-therapy study visit. Observed case analysis of the ITT dataset, per randomized treatment assignment. | Posted | Least Squares Mean | Standard Error | millimeters mercury (mm Hg) | Month 3 |
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Adverse events were collected for the duration of the study (1 year). An AE was any untoward medical occurrence in a patient administered a study medication, regardless of whether or not the event had a causal relationship with the medication.
This reporting group includes all participants randomized to study drug, as treated. Adverse events were obtained as solicited comments from the study patients and as 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 | Brinzolamide/Brimonidine | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months | 2 | 214 | 20 | 214 | ||
| EG001 | Brinzolamide | Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months | 6 | 226 | 26 | 226 | ||
| EG002 | Brimonidine | Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months | 2 | 220 | 1 | 220 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac pacemaker insertion | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment | Not related |
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| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment | Not related |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment | Related |
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| Amnesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment | Not related |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 | Systematic Assessment | Not related |
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| Angina pectoris | Cardiac disorders | MedDRA 13.0 | Systematic Assessment | Not related |
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| Collapse of lung | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment | Not related |
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| Vertebroplasty | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment | Not related |
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| Vulval neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment | Not related |
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| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment | Not related |
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| Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment | Not related |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Dysgeusia | Nervous system 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 |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| ≥65 years |
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| Male |
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| +7 hrs relative to 8 am dosing |
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| +9 hrs relative to 8 am dosing |
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