Trial Outcomes & Findings for Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma (NCT NCT00441883)

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

176 participants

Primary outcome timeframe

Baseline, 28 days

Results posted on

2020-09-14

Participant Flow

Participant milestones

Participant milestones
Measure	PF-03187207 0.024% AM PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% AM PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% PM PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% AM Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% PM Latanoprost 0.005% dosed in the evening
Overall Study STARTED	43	32	28	28	45
Overall Study ITT Population	43	30	30	30	43
Overall Study Per Protocol Population	38	29	25	24	38
Overall Study Safety Population	43	32	28	28	45
Overall Study COMPLETED	42	32	28	28	43
Overall Study NOT COMPLETED	1	0	0	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-03187207 0.024% AM n=43 Participants PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% AM n=30 Participants PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% PM n=30 Participants PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% AM n=30 Participants Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% PM n=43 Participants Latanoprost 0.005% dosed in the evening	Total n=176 Participants Total of all reporting groups
Age, Continuous	66.1 years STANDARD_DEVIATION 10.2 • n=5 Participants	61.9 years STANDARD_DEVIATION 10.9 • n=7 Participants	61.8 years STANDARD_DEVIATION 9.0 • n=5 Participants	62.1 years STANDARD_DEVIATION 11.3 • n=4 Participants	63.6 years STANDARD_DEVIATION 12.8 • n=21 Participants	63.4 years STANDARD_DEVIATION 11.0 • n=8 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	23 Participants n=4 Participants	27 Participants n=21 Participants	118 Participants n=8 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	7 Participants n=4 Participants	16 Participants n=21 Participants	58 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline, 28 days

Population: Per protocol population

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

Outcome measures
Measure	PF-03187207 0.024% AM n=38 Participants PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% AM n=29 Participants PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% PM n=25 Participants PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% AM n=24 Participants Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% PM n=38 Participants Latanoprost 0.005% dosed in the evening
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	-7.09 mmHg (milimeters of mercury) Standard Deviation 2.123	-8.20 mmHg (milimeters of mercury) Standard Deviation 4.011	-6.02 mmHg (milimeters of mercury) Standard Deviation 2.322	-7.28 mmHg (milimeters of mercury) Standard Deviation 2.871

SECONDARY outcome

Timeframe: Baseline, Day 7, Day 14, and Day 21

Population: Per protocol population

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.

Outcome measures

Outcome measures
Measure	PF-03187207 0.024% AM n=38 Participants PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% AM n=29 Participants PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% PM n=25 Participants PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% AM n=24 Participants Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% PM n=38 Participants Latanoprost 0.005% dosed in the evening
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 2.630	-7.20 mmHg (milimeters of mercury) Standard Deviation 2.555	-7.85 mmHg (milimeters of mercury) Standard Deviation 3.970	-5.49 mmHg (milimeters of mercury) Standard Deviation 1.926	-6.82 mmHg (milimeters of mercury) Standard Deviation 2.556
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	-7.34 mmHg (milimeters of mercury) Standard Deviation 2.579	-8.35 mmHg (milimeters of mercury) Standard Deviation 3.309	-5.81 mmHg (milimeters of mercury) Standard Deviation 2.625	-7.04 mmHg (milimeters of mercury) Standard Deviation 2.640
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	-7.20 mmHg (milimeters of mercury) Standard Deviation 2.595	-8.18 mmHg (milimeters of mercury) Standard Deviation 3.267	-5.27 mmHg (milimeters of mercury) Standard Deviation 2.679	-7.0 mmHg (milimeters of mercury) Standard Deviation 2.295

SECONDARY outcome

Timeframe: 28 days

Population: Per protocol population

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.