A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
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.
1 other identifier
interventional
117
1 country
13
Brief Summary
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2007
Shorter than P25 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 4, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
August 27, 2020
CompletedSeptember 14, 2020
September 1, 2020
6 months
January 4, 2008
August 12, 2020
September 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and Day 28
Baseline, Day 14, Day 28
Target IOP
Up to 28 days
Study Arms (4)
PF-03187207 High Dose and Latanoprost Vehicle
EXPERIMENTALA single drop of each, once daily in study eye for 28 days
Latanoprost 0.005% and PF-03187207 Vehicle
EXPERIMENTALA single drop of each, once daily in study eye for 28 days
PF-03187207 Medium Dose and Latanoprost Vehicle
EXPERIMENTALA single drop of each, once daily in study eye for 28 days
PF-03187207 Low Dose and Latanoprost Vehicle
EXPERIMENTALA single drop of each, once daily in study eye for 28 days
Interventions
One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
Eligibility Criteria
You may qualify if:
- Man or woman at least 20 years of age
- Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Pfizer Investigational Site
Narashino, Chiba, Japan
Pfizer Investigational Site
Shimachi, Chiba, Japan
Pfizer Investigational Site
Kawasaki, Kanagawa, Japan
Pfizer Investigational Site
Kasukabe, Saitama, Japan
Pfizer Investigational Site
Fuji, Shizuoka, Japan
Pfizer Investigational Site
Mishima, Shizuoka, Japan
Pfizer Investigational Site
Susono, Shizuoka, Japan
Pfizer Investigational Site
Hachiōji, Tokyo, Japan
Pfizer Investigational Site
Hamura, Tokyo, Japan
Pfizer Investigational Site
Minato, Tokyo, Japan
Pfizer Investigational Site
Musashino, Tokyo, Japan
Pfizer Investigational Site
Setagaya City, Tokyo, Japan
Pfizer Investigational Site
Shizuoka, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Ken Harper
Bausch & Lomb Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2008
First Posted
January 16, 2008
Study Start
December 1, 2007
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
September 14, 2020
Results First Posted
August 27, 2020
Record last verified: 2020-09