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| Name | Class |
|---|---|
| NicOx Inc. | INDUSTRY |
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This study will evaluate the safety and efficacy of PF 03187207.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-03187207 and Latanoprost Vehicle | Experimental | One drop of each, once daily in study eye for 28 days |
|
| Latanoprost 0.005% and PF-03187207 Vehicle | Active Comparator | One drop of each, once daily in study eye for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-03187207 and Latanoprost Vehicle | Drug |
| ||
| Latanoprost 0.005% and PF-03187207 Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | Baseline, 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. gBoth eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. |
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Inclusion Criteria:
-Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes
Exclusion Criteria:
-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Harper | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Artesia | California | 90701 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-03187207 0.024% AM | PF-03187207 0.024% dosed in the morning |
| FG001 | PF-03187207 0.040% AM | PF-03187207 0.040% dosed in the morning |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Baseline, Day 7, Day 14, and Day 21 |
| Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | 28 days |
| Newport Beach |
| California |
| 92663 |
| United States |
| Pfizer Investigational Site | Petaluma | California | 94954 | United States |
| Pfizer Investigational Site | Poway | California | 92064 | United States |
| Pfizer Investigational Site | Danbury | Connecticut | 06810-4004 | United States |
| Pfizer Investigational Site | Jacksonville | Florida | 32204 | United States |
| Pfizer Investigational Site | Ormond Beach | Florida | 32174 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30339 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30342 | United States |
| Pfizer Investigational Site | Evansville | Indiana | 47710 | United States |
| Pfizer Investigational Site | Louisville | Kentucky | 40217 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Pfizer Investigational Site | High Point | North Carolina | 27262 | United States |
| Pfizer Investigational Site | Tulsa | Oklahoma | 74104 | United States |
| Pfizer Investigational Site | Cranberry Township | Pennsylvania | 16066 | United States |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15238 | United States |
| Pfizer Investigational Site | Memphis | Tennessee | 38119 | United States |
| Pfizer Investigational Site | Austin | Texas | 78705 | United States |
| FG002 | PF-03187207 0.040% PM | PF-03187207 0.040% dosed in the evening |
| FG003 | Latanoprost 0.005% AM | Latanoprost 0.005% dosed in the morning |
| FG004 | Latanoprost 0.005% PM | Latanoprost 0.005% dosed in the evening |
| ITT Population | Participants randomized and at least 1 dose of study medication; by randomized treatment. |
|
| Per Protocol Population | Participant randomized with no major protocol violations; by treatment received. |
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| Safety Population | Participants randomized with at least 1 dose of study medication; by treatment received. |
|
| COMPLETED |
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| NOT COMPLETED |
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ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-03187207 0.024% AM | PF-03187207 0.024% dosed in the morning |
| BG001 | PF-03187207 0.040% AM | PF-03187207 0.040% dosed in the morning |
| BG002 | PF-03187207 0.040% PM | PF-03187207 0.040% dosed in the evening |
| BG003 | Latanoprost 0.005% AM | Latanoprost 0.005% dosed in the morning |
| BG004 | Latanoprost 0.005% PM | Latanoprost 0.005% dosed in the evening |
| BG005 | 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | Per protocol population | Posted | Mean | Standard Deviation | mmHg (milimeters of mercury) | Baseline, 28 days |
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|
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| Secondary | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. gBoth eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | Per protocol population | Posted | Mean | Standard Deviation | mmHg (milimeters of mercury) | Baseline, Day 7, Day 14, and Day 21 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point. | Per protocol population | Posted | Count of Participants | Participants | 28 days |
|
28 days
The safety population was utilized for adverse event summaries. The safety population included participants randomized with at least 1 dose of study medication; by treatment received even if randomized treatment assignment differed.
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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 | PF-03187207 0.024% AM | PF-03187207 0.024% dosed in the morning | 0 | 43 | 6 | 43 | ||
| EG001 | PF-03187207 0.040% AM | PF-03187207 0.040% dosed in the morning | 0 | 32 | 11 | 32 | ||
| EG002 | PF-03187207 0.040% PM | PF-03187207 0.040% dosed in the evening | 0 | 28 | 9 | 28 | ||
| EG003 | Latanoprost 0.005% AM | Latanoprost 0.005% dosed in the morning | 0 | 28 | 7 | 28 | ||
| EG004 | Latanoprost 0.005% PM | Latanoprost 0.005% dosed in the evening | 0 | 45 | 6 | 45 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis viral | Infections and infestations | MedDRA (10.1) | Non-systematic Assessment |
| |
| Conjunctival hyperaemia | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (10.1) | Non-systematic Assessment |
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Contact sponsor directly for details.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Bausch Health | 908-300-9920 | susan.harris@bauschhealth.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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| Male |
|
| OG003 |
| Latanoprost 0.005% AM |
Latanoprost 0.005% dosed in the morning |
| OG004 | Latanoprost 0.005% PM | Latanoprost 0.005% dosed in the evening |
|
|
| OG003 |
| Latanoprost 0.005% AM |
Latanoprost 0.005% dosed in the morning |
| OG004 | Latanoprost 0.005% PM | Latanoprost 0.005% dosed in the evening |
|
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