Primary Open Angle Glaucoma, Ocular Hypertension
Conditions
Brief summary
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
Interventions
DRUGPF-03187207
DRUGPF-03187207 Vehicle
One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Man or woman at least 20 years of age * Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.
Exclusion criteria
* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye * Contraindications to latanoprost and nitric oxide treatment * Known latanoprost non-responders
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 Specific Time Points on Day 14 and Day 28 | Baseline, Day 14, 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. |
| Target IOP | Up to 28 days | Percentage of participants with IOP of 18 mmHg or Lower, 16 mmHg or Lower, or 14 mmHg or Lower 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-0318 0.006% PF-0318 0.006% once daily in the evening | 29 |
| PF-0318 0.024% PF-0318 0.024% once daily in the evening | 29 |
| PF-0318 0.04% PF-0318 0.04% once daily in the evening | 29 |
| 0.005% Latanoprost 0.005% latanoprost once daily in the evening | 30 |
| Total | 117 |
Baseline characteristics
| Characteristic | PF-0318 0.006% | PF-0318 0.024% | PF-0318 0.04% | 0.005% Latanoprost | Total |
|---|---|---|---|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 12.2 | 60.9 years STANDARD_DEVIATION 18 | 58.8 years STANDARD_DEVIATION 15.1 | 60.0 years STANDARD_DEVIATION 17.3 | 59.5 years STANDARD_DEVIATION 15.7 |
| Sex: Female, Male Female | 13 Participants | 12 Participants | 18 Participants | 16 Participants | 59 Participants |
| Sex: Female, Male Male | 16 Participants | 17 Participants | 11 Participants | 14 Participants | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 29 | 3 / 29 | 5 / 29 | 2 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 | 0 / 29 | 0 / 30 |
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: The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-0318 0.006% | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -5.12 mmHg (milimeters of mercury) | Standard Deviation 2.55 |
| PF-0318 0.024% | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -5.94 mmHg (milimeters of mercury) | Standard Deviation 3.09 |
| PF-0318 0.04% | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -5.02 mmHg (milimeters of mercury) | Standard Deviation 2.03 |
| 0.005% Latanoprost | Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | -5.25 mmHg (milimeters of mercury) | Standard Deviation 2.53 |
Secondary
Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and 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: Baseline, Day 14, Day 28
Population: The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-0318 0.006% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 2pm | -4.57 mmHg (milimeters of mercury) | Standard Deviation 2.77 |
| PF-0318 0.006% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 9am | -5.63 mmHg (milimeters of mercury) | Standard Deviation 3.29 |
| PF-0318 0.006% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 5pm | -4.68 mmHg (milimeters of mercury) | Standard Deviation 2.47 |
| PF-0318 0.006% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 11am | -5.61 mmHg (milimeters of mercury) | Standard Deviation 3.2 |
| PF-0318 0.006% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 14, 9am | -5.20 mmHg (milimeters of mercury) | Standard Deviation 2.97 |
| PF-0318 0.024% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 11am | -6.07 mmHg (milimeters of mercury) | Standard Deviation 3.31 |
| PF-0318 0.024% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 2pm | -5.28 mmHg (milimeters of mercury) | Standard Deviation 3.17 |
| PF-0318 0.024% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 5pm | -6.28 mmHg (milimeters of mercury) | Standard Deviation 3.56 |
| PF-0318 0.024% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 9am | -6.11 mmHg (milimeters of mercury) | Standard Deviation 3.82 |
| PF-0318 0.024% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 14, 9am | -5.87 mmHg (milimeters of mercury) | Standard Deviation 3.21 |
| PF-0318 0.04% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 11am | -5.46 mmHg (milimeters of mercury) | Standard Deviation 2.56 |
| PF-0318 0.04% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 14, 9am | -4.35 mmHg (milimeters of mercury) | Standard Deviation 2.76 |
| PF-0318 0.04% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 9am | -5.19 mmHg (milimeters of mercury) | Standard Deviation 2.71 |
| PF-0318 0.04% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 2pm | -4.85 mmHg (milimeters of mercury) | Standard Deviation 2.11 |
| PF-0318 0.04% | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 5pm | -4.57 mmHg (milimeters of mercury) | Standard Deviation 2.53 |
| 0.005% Latanoprost | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 2pm | -5.27 mmHg (milimeters of mercury) | Standard Deviation 3.11 |
| 0.005% Latanoprost | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 9am | -5.33 mmHg (milimeters of mercury) | Standard Deviation 2.66 |
| 0.005% Latanoprost | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 14, 9am | -5.53 mmHg (milimeters of mercury) | Standard Deviation 2.53 |
| 0.005% Latanoprost | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 11am | -5.65 mmHg (milimeters of mercury) | Standard Deviation 2.8 |
| 0.005% Latanoprost | Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28 | Day 28, 5pm | -4.73 mmHg (milimeters of mercury) | Standard Deviation 2.93 |
Secondary
Target IOP
Percentage of participants with IOP of 18 mmHg or Lower, 16 mmHg or Lower, or 14 mmHg or Lower 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: Up to 28 days
Population: The Per Protocol (PP) population consisted of all subjects in the intention to treat (ITT) population excluding those who made major protocol violations before completing the study. The PP population was considered as the primary analysis population of efficacy (primary and secondary endpoints) of the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-0318 0.006% | Target IOP | 18 mmHg or lower | 9 Participants |
| PF-0318 0.006% | Target IOP | 14 mmHg or lower | 0 Participants |
| PF-0318 0.006% | Target IOP | 16 mmHg or lower | 4 Participants |
| PF-0318 0.024% | Target IOP | 18 mmHg or lower | 11 Participants |
| PF-0318 0.024% | Target IOP | 14 mmHg or lower | 1 Participants |
| PF-0318 0.024% | Target IOP | 16 mmHg or lower | 2 Participants |
| PF-0318 0.04% | Target IOP | 16 mmHg or lower | 3 Participants |
| PF-0318 0.04% | Target IOP | 18 mmHg or lower | 13 Participants |
| PF-0318 0.04% | Target IOP | 14 mmHg or lower | 0 Participants |
| 0.005% Latanoprost | Target IOP | 18 mmHg or lower | 9 Participants |
| 0.005% Latanoprost | Target IOP | 14 mmHg or lower | 2 Participants |
| 0.005% Latanoprost | Target IOP | 16 mmHg or lower | 3 Participants |