Ocular Hypertension, Pigmentary Glaucoma, Primary Open Angle Glaucoma, Pseudoexfoliative Glaucoma
Conditions
Brief summary
This study will evaluate the safety and efficacy of PF 03187207.
Interventions
DRUGPF-03187207 and Latanoprost Vehicle
DRUGLatanoprost 0.005% and PF-03187207 Vehicle
Sponsors
NicOx Inc.
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | Baseline, 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Baseline, Day 7, Day 14, and Day 21 | 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. |
| Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | 28 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-03187207 0.024% AM PF-03187207 0.024% dosed in the morning | 43 |
| PF-03187207 0.040% AM PF-03187207 0.040% dosed in the morning | 30 |
| PF-03187207 0.040% PM PF-03187207 0.040% dosed in the evening | 30 |
| Latanoprost 0.005% AM Latanoprost 0.005% dosed in the morning | 30 |
| Latanoprost 0.005% PM Latanoprost 0.005% dosed in the evening | 43 |
| Total | 176 |
Baseline characteristics
| Characteristic | PF-03187207 0.024% AM | PF-03187207 0.040% AM | PF-03187207 0.040% PM | Latanoprost 0.005% AM | Latanoprost 0.005% PM | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 66.1 years STANDARD_DEVIATION 10.2 | 61.9 years STANDARD_DEVIATION 10.9 | 61.8 years STANDARD_DEVIATION 9 | 62.1 years STANDARD_DEVIATION 11.3 | 63.6 years STANDARD_DEVIATION 12.8 | 63.4 years STANDARD_DEVIATION 11 |
| Sex: Female, Male Female | 27 Participants | 21 Participants | 20 Participants | 23 Participants | 27 Participants | 118 Participants |
| Sex: Female, Male Male | 16 Participants | 9 Participants | 10 Participants | 7 Participants | 16 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 43 | 11 / 32 | 9 / 28 | 7 / 28 | 6 / 45 |
| serious Total, serious adverse events | 0 / 43 | 0 / 32 | 0 / 28 | 0 / 28 | 0 / 45 |
Outcome results
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.
Time frame: Baseline, 28 days
Population: Per protocol population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-03187207 0.024% AM | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -6.96 mmHg (milimeters of mercury) | Standard Deviation 2.772 |
| PF-03187207 0.040% AM | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -7.09 mmHg (milimeters of mercury) | Standard Deviation 2.123 |
| PF-03187207 0.040% PM | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -8.20 mmHg (milimeters of mercury) | Standard Deviation 4.011 |
| Latanoprost 0.005% AM | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -6.02 mmHg (milimeters of mercury) | Standard Deviation 2.322 |
| Latanoprost 0.005% PM | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -7.28 mmHg (milimeters of mercury) | Standard Deviation 2.871 |
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.
Time frame: Baseline, Day 7, Day 14, and Day 21
Population: Per protocol population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-03187207 0.024% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 7 | -6.58 mmHg (milimeters of mercury) | Standard Deviation 2.63 |
| PF-03187207 0.024% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 21 | -6.68 mmHg (milimeters of mercury) | Standard Deviation 2.133 |
| PF-03187207 0.024% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 14 | -7.20 mmHg (milimeters of mercury) | Standard Deviation 2.776 |
| PF-03187207 0.040% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 14 | -7.20 mmHg (milimeters of mercury) | Standard Deviation 2.595 |
| PF-03187207 0.040% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 7 | -7.20 mmHg (milimeters of mercury) | Standard Deviation 2.555 |
| PF-03187207 0.040% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 21 | -7.34 mmHg (milimeters of mercury) | Standard Deviation 2.579 |
| PF-03187207 0.040% PM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 14 | -8.18 mmHg (milimeters of mercury) | Standard Deviation 3.267 |
| PF-03187207 0.040% PM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 7 | -7.85 mmHg (milimeters of mercury) | Standard Deviation 3.97 |
| PF-03187207 0.040% PM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 21 | -8.35 mmHg (milimeters of mercury) | Standard Deviation 3.309 |
| Latanoprost 0.005% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 7 | -5.49 mmHg (milimeters of mercury) | Standard Deviation 1.926 |
| Latanoprost 0.005% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 21 | -5.81 mmHg (milimeters of mercury) | Standard Deviation 2.625 |
| Latanoprost 0.005% AM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 14 | -5.27 mmHg (milimeters of mercury) | Standard Deviation 2.679 |
| Latanoprost 0.005% PM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 14 | -7.0 mmHg (milimeters of mercury) | Standard Deviation 2.295 |
| Latanoprost 0.005% PM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 7 | -6.82 mmHg (milimeters of mercury) | Standard Deviation 2.556 |
| Latanoprost 0.005% PM | Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits | Day 21 | -7.04 mmHg (milimeters of mercury) | Standard Deviation 2.64 |
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.
Time frame: 28 days
Population: Per protocol population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-03187207 0.024% AM | Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | 1 Participants |
| PF-03187207 0.040% AM | Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | 1 Participants |
| PF-03187207 0.040% PM | Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | 3 Participants |
| Latanoprost 0.005% AM | Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | 0 Participants |
| Latanoprost 0.005% PM | Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 | 2 Participants |