Trial Outcomes & Findings for A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension. (NCT NCT00595101)
NCT ID: NCT00595101
Last Updated: 2020-09-14
Results Overview
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.
COMPLETED
PHASE2
117 participants
Baseline, 28 days
2020-09-14
Participant Flow
Participant milestones
| Measure |
PF-0318 0.006%
PF-0318 0.006% once daily in the evening
|
PF-0318 0.024%
PF-0318 0.024% once daily in the evening
|
PF-0318 0.04%
PF-0318 0.04% once daily in the evening
|
0.005% Latanoprost
0.005% latanoprost once daily in the evening
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
29
|
30
|
|
Overall Study
COMPLETED
|
29
|
28
|
29
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
Baseline characteristics by cohort
| Measure |
PF-0318 0.006%
n=29 Participants
PF-0318 0.006% once daily in the evening
|
PF-0318 0.024%
n=29 Participants
PF-0318 0.024% once daily in the evening
|
PF-0318 0.04%
n=29 Participants
PF-0318 0.04% once daily in the evening
|
0.005% Latanoprost
n=30 Participants
0.005% latanoprost once daily in the evening
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 18.0 • n=7 Participants
|
58.8 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 17.3 • n=4 Participants
|
59.5 years
STANDARD_DEVIATION 15.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
PF-0318 0.006%
n=28 Participants
PF-0318 0.006% once daily in the evening
|
PF-0318 0.024%
n=27 Participants
PF-0318 0.024% once daily in the evening
|
PF-0318 0.04%
n=27 Participants
PF-0318 0.04% once daily in the evening
|
0.005% Latanoprost
n=30 Participants
0.005% latanoprost once daily in the evening
|
|---|---|---|---|---|
|
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
|
-5.94 mmHg (milimeters of mercury)
Standard Deviation 3.09
|
-5.02 mmHg (milimeters of mercury)
Standard Deviation 2.03
|
-5.25 mmHg (milimeters of mercury)
Standard Deviation 2.53
|
SECONDARY outcome
Timeframe: Baseline, Day 14, Day 28Population: 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.
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.
Outcome measures
| Measure |
PF-0318 0.006%
n=28 Participants
PF-0318 0.006% once daily in the evening
|
PF-0318 0.024%
n=27 Participants
PF-0318 0.024% once daily in the evening
|
PF-0318 0.04%
n=27 Participants
PF-0318 0.04% once daily in the evening
|
0.005% Latanoprost
n=30 Participants
0.005% latanoprost once daily in the evening
|
|---|---|---|---|---|
|
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
|
-5.28 mmHg (milimeters of mercury)
Standard Deviation 3.17
|
-4.85 mmHg (milimeters of mercury)
Standard Deviation 2.11
|
-5.27 mmHg (milimeters of mercury)
Standard Deviation 3.11
|
|
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
|
-6.28 mmHg (milimeters of mercury)
Standard Deviation 3.56
|
-4.57 mmHg (milimeters of mercury)
Standard Deviation 2.53
|
-4.73 mmHg (milimeters of mercury)
Standard Deviation 2.93
|
|
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
|
-5.87 mmHg (milimeters of mercury)
Standard Deviation 3.21
|
-4.35 mmHg (milimeters of mercury)
Standard Deviation 2.76
|
-5.53 mmHg (milimeters of mercury)
Standard Deviation 2.53
|
|
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
|
-6.11 mmHg (milimeters of mercury)
Standard Deviation 3.82
|
-5.19 mmHg (milimeters of mercury)
Standard Deviation 2.71
|
-5.33 mmHg (milimeters of mercury)
Standard Deviation 2.66
|
|
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 3.20
|
-6.07 mmHg (milimeters of mercury)
Standard Deviation 3.31
|
-5.46 mmHg (milimeters of mercury)
Standard Deviation 2.56
|
-5.65 mmHg (milimeters of mercury)
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Up to 28 daysPopulation: 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.
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.
Outcome measures
| Measure |
PF-0318 0.006%
n=28 Participants
PF-0318 0.006% once daily in the evening
|
PF-0318 0.024%
n=27 Participants
PF-0318 0.024% once daily in the evening
|
PF-0318 0.04%
n=27 Participants
PF-0318 0.04% once daily in the evening
|
0.005% Latanoprost
n=30 Participants
0.005% latanoprost once daily in the evening
|
|---|---|---|---|---|
|
Target IOP
16 mmHg or lower
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Target IOP
18 mmHg or lower
|
9 Participants
|
11 Participants
|
13 Participants
|
9 Participants
|
|
Target IOP
14 mmHg or lower
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
Adverse Events
PF-0318 0.006%
PF-0318 0.024%
PF-0318 0.04%
0.005% Latanoprost
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-0318 0.006%
n=29 participants at risk
PF-0318 0.006% once daily in the evening
|
PF-0318 0.024%
n=29 participants at risk
PF-0318 0.024% once daily in the evening
|
PF-0318 0.04%
n=29 participants at risk
PF-0318 0.04% once daily in the evening
|
0.005% Latanoprost
n=30 participants at risk
0.005% latanoprost once daily in the evening
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/29 • 28 days
|
10.3%
3/29 • 28 days
|
0.00%
0/29 • 28 days
|
0.00%
0/30 • 28 days
|
|
Eye disorders
Ocular hyperaemia
|
3.4%
1/29 • 28 days
|
3.4%
1/29 • 28 days
|
6.9%
2/29 • 28 days
|
3.3%
1/30 • 28 days
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
1/29 • 28 days
|
3.4%
1/29 • 28 days
|
10.3%
3/29 • 28 days
|
6.7%
2/30 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details
- Publication restrictions are in place
Restriction type: OTHER