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

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
PF-03187207
Latanoprost 0.005%
PF-03187207 Vehicle
Latanoprost Vehicle
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

PF-03187207 High Dose and Latanoprost Vehicle

Latanoprost 0.005% and PF-03187207 Vehicle

PF-03187207 Medium Dose and Latanoprost Vehicle

PF-03187207 Low Dose and Latanoprost Vehicle

Arm Description

A single drop of each, once daily in study eye for 28 days

A single drop of each, once daily in study eye for 28 days

A single drop of each, once daily in study eye for 28 days

A single drop of each, once daily in study eye for 28 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 4, 2008
Last Updated
September 10, 2020
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00595101
Brief Title
A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-03187207 High Dose and Latanoprost Vehicle
Arm Type
Experimental
Arm Description
A single drop of each, once daily in study eye for 28 days
Arm Title
Latanoprost 0.005% and PF-03187207 Vehicle
Arm Type
Experimental
Arm Description
A single drop of each, once daily in study eye for 28 days
Arm Title
PF-03187207 Medium Dose and Latanoprost Vehicle
Arm Type
Experimental
Arm Description
A single drop of each, once daily in study eye for 28 days
Arm Title
PF-03187207 Low Dose and Latanoprost Vehicle
Arm Type
Experimental
Arm Description
A single drop of each, once daily in study eye for 28 days
Intervention Type
Drug
Intervention Name(s)
PF-03187207
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Intervention Type
Drug
Intervention Name(s)
PF-03187207 Vehicle
Intervention Description
One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
Intervention Type
Drug
Intervention Name(s)
Latanoprost Vehicle
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and 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
Baseline, Day 14, Day 28
Title
Target IOP
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Harper
Organizational Affiliation
Bausch & Lomb Incorporated
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Narashino
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shimachi
State/Province
Chiba
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Pfizer Investigational Site
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Pfizer Investigational Site
City
Fuji
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Mishima
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Susono
State/Province
Shizuoka
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hachioji
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Hamura
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Musashino
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Pfizer Investigational Site
City
Shizuoka
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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