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The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azopt 1% ophthalmic suspension | Active Comparator | Ophthalmic suspension |
|
| Brinzolamide 1% ophthalmic suspension | Experimental | ophthalmic suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brinzolamide 1% ophthalmic suspension | Drug | brinzolamide 1% ophthalmic suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure (IOP) at Week 12 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline to Week 12 | Baseline, Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US01 | Louisville | Kentucky | 40217 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brinzolamide 1% Ophthalmic Suspension | ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension |
| FG001 | Azopt 1% Ophthalmic Suspension | Ophthalmic suspension Azopt 1%: Azopt 1%, RLD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brinzolamide 1% Ophthalmic Suspension | ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension |
| BG001 | Azopt 1% Ophthalmic Suspension |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Intraocular Pressure (IOP) at Week 12 | The Per Protocol (PP) Population was utilized for the primary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population. | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
12 weeks
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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 1% Ophthalmic Suspension | ophthalmic suspension brinzolamide 1% ophthalmic suspension: brinzolamide 1% ophthalmic suspension |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site complication | General disorders | MedDRA (15.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Donatello | Bausch & Lomb | (585) 338-5306 | Daniel.Donatello@bausch.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
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| Azopt 1% | Drug | Azopt 1%, RLD |
|
Ophthalmic suspension
Azopt 1%: Azopt 1%, RLD
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Change in Intraocular Pressure (IOP) From Baseline to Week 12 | The Per Protocol (PP) Population was utilized for the secondary outcome. All randomized participants who completed both the baseline visit (eligibility visit 2) and the week 12 visit and who had no major protocol violations, and who also completed week 4 and week 8 visits, were included in the PP population. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12 |
|
|
|
| 0 |
| 129 |
| 2 |
| 129 |
| 9 |
| 129 |
| EG001 | Azopt 1% Ophthalmic Suspension | Ophthalmic suspension Azopt 1%: Azopt 1%, RLD | 0 | 129 | 3 | 129 | 5 | 129 |
| Coronary artery disease | Cardiac disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Diverticulitis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA (15.0) | Non-systematic Assessment |
|
| Arthropathy | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Non-systematic Assessment |
|
Please contact sponsor directly for details.