Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/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 the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brinz/Brim | Experimental | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months |
|
| Brinzolamide | Active Comparator | Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months |
|
| Brimonidine | Active Comparator | Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months |
|
| 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 Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3 | The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Teague, BS, Sr. Clinical Manager | Alcon Research | Study Director |
Not provided
Of the 1062 enrolled, 372 subjects did not meet inclusion/exclusion criteria and were exited from the study as screen failures prior to randomization. This reporting group includes all randomized subjects (690), as treated.
Subjects were recruited and enrolled from 64 investigational centers in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Brinz/Brim | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months |
| FG001 | Brinzolamide | Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| Brimonidine tartrate ophthalmic solution, 0.2% | Drug |
|
| FG002 | Brimonidine | Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months |
| COMPLETED |
|
| NOT COMPLETED |
|
|
This reporting group includes all randomized subjects, as treated.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Brinz/Brim | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months |
| BG001 | Brinzolamide | Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months |
| BG002 | Brimonidine | Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3 | The study drug was instilled at 8 AM and 3 PM (approximately 15 minutes after conducting the IOP measurements). 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 subjects 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 |
|
|
|
Adverse events were collected for the duration of the study. The safety population includes all subjects who were exposed to study drug.
An adverse event was any untoward medical occurrence in a subject exposed to study drug. The AE did not necessarily have to have had a causal relationship with the study drug. Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol.
Not provided
| 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 | Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months | 7 | 221 | 53 | 221 | ||
| EG001 | Brinzolamide | Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months | 7 | 234 | 35 | 234 | ||
| EG002 | Brimonidine | Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months | 7 | 235 | 27 | 235 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abscess | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Aortic aneurysm repair | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Prostatectomy | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Retinal tear | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intervertebral disc operation | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Knee arthroplasty | Surgical and medical procedures | MedDRA 13.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Otitis media chronic | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Eye allergy | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C111827 | brinzolamide |
| D000068438 | Brimonidine Tartrate |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| ≥65 years |
|
| Male |
|
|
| + 7 hours relative to 8 AM dosing |
|
| + 9 hours relative to 8 AM dosing |
|