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

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00441883
• Collaborator: NicOx Inc. (Industry)
• Enrollment: 176
• Locations: 19
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of PF 03187207.

Condition or Disease	Intervention/Treatment	Phase
Primary Open Angle Glaucoma; Ocular Hypertension; Pigmentary Glaucoma; Pseudoexfoliative Glaucoma	Drug: PF-03187207 and Latanoprost Vehicle; Drug: Latanoprost 0.005% and PF-03187207 Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Feb 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-03187207 and Latanoprost Vehicle One drop of each, once daily in study eye for 28 days	Drug: PF-03187207 and Latanoprost Vehicle
Active Comparator: Latanoprost 0.005% and PF-03187207 Vehicle One drop of each, once daily in study eye for 28 days	Drug: Latanoprost 0.005% and PF-03187207 Vehicle

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Artesia	California	United States	90701
2	Pfizer Investigational Site	Newport Beach	California	United States	92663
3	Pfizer Investigational Site	Petaluma	California	United States	94954
4	Pfizer Investigational Site	Poway	California	United States	92064
5	Pfizer Investigational Site	Danbury	Connecticut	United States	06810-4004
6	Pfizer Investigational Site	Jacksonville	Florida	United States	32204
7	Pfizer Investigational Site	Ormond Beach	Florida	United States	32174
8	Pfizer Investigational Site	Atlanta	Georgia	United States	30339
9	Pfizer Investigational Site	Atlanta	Georgia	United States	30342
10	Pfizer Investigational Site	Evansville	Indiana	United States	47710
11	Pfizer Investigational Site	Louisville	Kentucky	United States	40217
12	Pfizer Investigational Site	Rochester	New York	United States	14618
13	Pfizer Investigational Site	Charlotte	North Carolina	United States	28210
14	Pfizer Investigational Site	High Point	North Carolina	United States	27262
15	Pfizer Investigational Site	Tulsa	Oklahoma	United States	74104
16	Pfizer Investigational Site	Cranberry Township	Pennsylvania	United States	16066
17	Pfizer Investigational Site	Pittsburgh	Pennsylvania	United States	15238
18	Pfizer Investigational Site	Memphis	Tennessee	United States	38119
19	Pfizer Investigational Site	Austin	Texas	United States	78705

Sponsors and Collaborators

• Bausch & Lomb Incorporated
• NicOx Inc.

Investigators

• Study Director: Kenneth Harper, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00441883
• Other Study ID Numbers: A9441001
• First Posted: Mar 1, 2007
• Last Update Posted: Sep 14, 2020
• Last Verified: Sep 1, 2020

• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Latanoprost

Study Results

Participant Flow

Arm/Group Title	PF-03187207 0.024% AM	PF-03187207 0.040% AM	PF-03187207 0.040% PM	Latanoprost 0.005% AM	Latanoprost 0.005% PM
Arm/Group Description	PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% dosed in the evening
Period Title: Overall Study
STARTED	43	32	28	28	45
ITT Population	43	30	30	30	43
Per Protocol Population	38	29	25	24	38
Safety Population	43	32	28	28	45
COMPLETED	42	32	28	28	43
NOT COMPLETED	1	0	0	0	2

Baseline Characteristics

Arm/Group Title	PF-03187207 0.024% AM	PF-03187207 0.040% AM	PF-03187207 0.040% PM	Latanoprost 0.005% AM	Latanoprost 0.005% PM	Total
Arm/Group Description	PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% dosed in the evening	Total of all reporting groups
Overall Participants	43	30	30	30	43	176
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.1 (10.2)	61.9 (10.9)	61.8 (9.0)	62.1 (11.3)	63.6 (12.8)	63.4 (11.0)
Sex: Female, Male (Count of Participants)
Female	27 62.8%	21 70%	20 66.7%	23 76.7%	27 62.8%	118 67%
Male	16 37.2%	9 30%	10 33.3%	7 23.3%	16 37.2%	58 33%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28
Description	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

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	PF-03187207 0.024% AM	PF-03187207 0.040% AM	PF-03187207 0.040% PM	Latanoprost 0.005% AM	Latanoprost 0.005% PM
Arm/Group Description	PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% dosed in the evening
Measure Participants	38	29	25	24	38
Mean (Standard Deviation) [mmHg (milimeters of mercury)]	-6.96 (2.772)	-7.09 (2.123)	-8.20 (4.011)	-6.02 (2.322)	-7.28 (2.871)

2. Secondary Outcome

Title	Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits
Description	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

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	PF-03187207 0.024% AM	PF-03187207 0.040% AM	PF-03187207 0.040% PM	Latanoprost 0.005% AM	Latanoprost 0.005% PM
Arm/Group Description	PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% dosed in the evening
Measure Participants	38	29	25	24	38
Day 7	-6.58 (2.630)	-7.20 (2.555)	-7.85 (3.970)	-5.49 (1.926)	-6.82 (2.556)
Day 14	-7.20 (2.776)	-7.20 (2.595)	-8.18 (3.267)	-5.27 (2.679)	-7.0 (2.295)
Day 21	-6.68 (2.133)	-7.34 (2.579)	-8.35 (3.309)	-5.81 (2.625)	-7.04 (2.640)

3. Secondary Outcome

Title	Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28
Description	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

Outcome Measure Data

Analysis Population Description

Per protocol population

Arm/Group Title	PF-03187207 0.024% AM	PF-03187207 0.040% AM	PF-03187207 0.040% PM	Latanoprost 0.005% AM	Latanoprost 0.005% PM
Arm/Group Description	PF-03187207 0.024% dosed in the morning	PF-03187207 0.040% dosed in the morning	PF-03187207 0.040% dosed in the evening	Latanoprost 0.005% dosed in the morning	Latanoprost 0.005% dosed in the evening
Measure Participants	38	29	25	24	38
Count of Participants [Participants]	1 2.3%	1 3.3%	3 10%	0 0%	2 4.7%

Adverse Events

Time Frame	28 days
Adverse Event Reporting Description	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.
Arm/Group Title	PF-03187207 0.024% AM		PF-03187207 0.040% AM		PF-03187207 0.040% PM		Latanoprost 0.005% AM		Latanoprost 0.005% PM
Arm/Group Description	PF-03187207 0.024% dosed in the morning		PF-03187207 0.040% dosed in the morning		PF-03187207 0.040% dosed in the evening		Latanoprost 0.005% dosed in the morning		Latanoprost 0.005% dosed in the evening
All Cause Mortality
	PF-03187207 0.024% AM		PF-03187207 0.040% AM		PF-03187207 0.040% PM		Latanoprost 0.005% AM		Latanoprost 0.005% PM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PF-03187207 0.024% AM		PF-03187207 0.040% AM		PF-03187207 0.040% PM		Latanoprost 0.005% AM		Latanoprost 0.005% PM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/32 (0%)		0/28 (0%)		0/28 (0%)		0/45 (0%)
Other (Not Including Serious) Adverse Events
	PF-03187207 0.024% AM		PF-03187207 0.040% AM		PF-03187207 0.040% PM		Latanoprost 0.005% AM		Latanoprost 0.005% PM
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/43 (14%)		11/32 (34.4%)		9/28 (32.1%)		7/28 (25%)		6/45 (13.3%)
Eye disorders
Conjunctival hyperaemia	5/43 (11.6%)		2/32 (6.3%)		1/28 (3.6%)		1/28 (3.6%)		4/45 (8.9%)
Eye irritation	0/43 (0%)		2/32 (6.3%)		3/28 (10.7%)		2/28 (7.1%)		1/45 (2.2%)
Eye pain	0/43 (0%)		3/32 (9.4%)		1/28 (3.6%)		1/28 (3.6%)		0/45 (0%)
Ocular hyperaemia	1/43 (2.3%)		1/32 (3.1%)		2/28 (7.1%)		0/28 (0%)		1/45 (2.2%)
Photophobia	0/43 (0%)		2/32 (6.3%)		0/28 (0%)		0/28 (0%)		0/45 (0%)
Vision blurred	0/43 (0%)		1/32 (3.1%)		0/28 (0%)		3/28 (10.7%)		0/45 (0%)
Infections and infestations
Gastroenteritis viral	0/43 (0%)		0/32 (0%)		2/28 (7.1%)		0/28 (0%)		0/45 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.