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The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM
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) | 6 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure (IOP) | Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Mathew | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Various | Bridgewater | New Jersey | 08807 | 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) | The Per Protocol Population was utilized for the primary outcome, included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation. | Posted | Mean | Standard Deviation | mmHg | 6 weeks |
|
6 weeks
One Brinzolamide participant did not receive treatment and is not included in the participant counts for safety. Two Brinzolamide participants received at least one dose of Azopt in error, and therefore the Azopt group has 2 additional participants for safety.
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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 |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Donatello | Bausch & Lomb | 5853385306 | Daniel.Donatello@bausch.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2018 | May 14, 2021 | Prot_SAP_000.pdf |
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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 |
|
Ophthalmic suspension Azopt 1%: Azopt 1%, RLD |
|
|
| Other Pre-specified | Change in Intraocular Pressure (IOP) | Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment. | The Per Protocol Population was utilized for this outcome; included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation. | Posted | Mean | Standard Deviation | mmHg | 6 weeks |
|
|
|
| 0 |
| 320 |
| 0 |
| 320 |
| 15 |
| 320 |
| EG001 | Azopt 1% Ophthalmic Suspension | Ophthalmic suspension Azopt 1%: Azopt 1%, RLD | 0 | 318 | 2 | 318 | 22 | 318 |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Contact sponsor directly for details.