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To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Perrigo active | Experimental |
| |
| Reference active | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brinzolamide/brimonidine ophthalmic suspension | Drug | Test product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Intra-ocular Pressure | mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James D. Branch Ophthalmology | Winston-Salem | North Carolina | 27101 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Perrigo Active | Brinzolamide/brimonidine ophthalmic suspension: Test product |
| FG001 | Reference Active | Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 27, 2021 | Feb 24, 2025 |
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| Simbrinza 0.2%/1% Ophthalmic Suspension |
| Drug |
Reference product |
|
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Perrigo Active | Brinzolamide/brimonidine ophthalmic suspension: Test product |
| BG001 | Reference Active | Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product |
| BG002 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Iris color | 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 Change in Intra-ocular Pressure | mean change in intra-ocular pressure of both eyes between the two treatment groups at four time points: at approximately 8:00 a.m. (hour 0; before the morning drop) and approximately 10:00 a.m. (hour 2) on Day 14 (Week 2) and Day 42 (Week 6) visits. Mean change from baseline to Day X Hour Y for each subject was derived as the average of (Day X Hour Y - Day 0 Hour Y) from the left and right eyes, where X = 14, 42. and Y = 0, 2. A negative value indicates an improvement | Posted | Mean | Standard Deviation | mmHG | 6 weeks |
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|
|
Day 1 to Day 46
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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 | Perrigo Active | Brinzolamide/brimonidine ophthalmic suspension: Test product | 1 | 221 | 2 | 221 | 32 | 221 |
| EG001 | Reference Active | Simbrinza 0.2%/1% Ophthalmic Suspension: Reference product | 0 | 226 | 4 | 226 | 22 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| coronary heart disease | Cardiac disorders | Non-systematic Assessment |
| ||
| subarachnoid hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Worsening of Left Carotid Artery Stenosis | Nervous system disorders | Non-systematic Assessment |
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| acute right temporal ischemic stroke | Nervous system disorders | Non-systematic Assessment |
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| COVID-19 virus infection | Infections and infestations | Non-systematic Assessment |
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| Diabetic Ketoacidoses | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Respiratory failure with hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | Non-systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Schwartz | Padagis LLC | 929-502-7291 | jonathan.schwartz@padagis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 27, 2021 | Feb 24, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C111827 | brinzolamide |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Right eye - Light |
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| Left eye - Dark |
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| Left eye - Light |
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| 8AM Day 42 |
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| 10AM Day 42 |
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| Mean Difference (Net) |
| -0.35 |
| 2-Sided |
| 95 |
| -0.86 |
| 0.26 |
| Equivalence |
10AM Day 14 |
| Mean Difference (Net) | -0.04 | 2-Sided | 95 | -0.58 | 0.58 | Equivalence | 8AM Day 42 |
| Mean Difference (Net) | -0.16 | 2-Sided | 95 | -0.70 | 0.47 | Equivalence | 10AM Day 42 |