A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.

Ocular Hypertension Clinical Trial

Official title:

A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595101
• Other study ID #: A9441003
• Status: Completed
• Phase: Phase 2
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• PF-03187207

• Latanoprost 0.005%

• PF-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.
• Latanoprost Vehicle

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Fuji	Shizuoka
Japan	Pfizer Investigational Site	Hachioji	Tokyo
Japan	Pfizer Investigational Site	Hamura	Tokyo
Japan	Pfizer Investigational Site	Kasukabe	Saitama
Japan	Pfizer Investigational Site	Kawasaki	Kanagawa
Japan	Pfizer Investigational Site	Minato	Tokyo
Japan	Pfizer Investigational Site	Mishima	Shizuoka
Japan	Pfizer Investigational Site	Musashino	Tokyo
Japan	Pfizer Investigational Site	Narashino	Chiba
Japan	Pfizer Investigational Site	Setagaya	Tokyo
Japan	Pfizer Investigational Site	Shimachi	Chiba
Japan	Pfizer Investigational Site	Shizuoka
Japan	Pfizer Investigational Site	Susono	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, 28 days
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.	Baseline, Day 14, Day 28
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.	Up to 28 days