Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma
A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost
1 other identifier
interventional
176
1 country
19
Brief Summary
This study will evaluate the safety and efficacy of PF 03187207.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2007
Shorter than P25 for phase_2
19 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
First Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedStudy Start
First participant enrolled
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
August 27, 2020
CompletedSeptember 14, 2020
September 1, 2020
11 months
February 27, 2007
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 the Day 7, 14, and 21 Visits
Baseline, Day 7, Day 14, and Day 21
Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28
28 days
Study Arms (2)
PF-03187207 and Latanoprost Vehicle
EXPERIMENTALOne drop of each, once daily in study eye for 28 days
Latanoprost 0.005% and PF-03187207 Vehicle
ACTIVE COMPARATOROne drop of each, once daily in study eye for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes
You may not qualify if:
- Closed or barely open anterior chamber angle or a history of acute angle closure in either eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bausch & Lomb Incorporatedlead
- NicOx Inc.collaborator
Study Sites (19)
Pfizer Investigational Site
Artesia, California, 90701, United States
Pfizer Investigational Site
Newport Beach, California, 92663, United States
Pfizer Investigational Site
Petaluma, California, 94954, United States
Pfizer Investigational Site
Poway, California, 92064, United States
Pfizer Investigational Site
Danbury, Connecticut, 06810-4004, United States
Pfizer Investigational Site
Jacksonville, Florida, 32204, United States
Pfizer Investigational Site
Ormond Beach, Florida, 32174, United States
Pfizer Investigational Site
Atlanta, Georgia, 30339, United States
Pfizer Investigational Site
Atlanta, Georgia, 30342, United States
Pfizer Investigational Site
Evansville, Indiana, 47710, United States
Pfizer Investigational Site
Louisville, Kentucky, 40217, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Charlotte, North Carolina, 28210, United States
Pfizer Investigational Site
High Point, North Carolina, 27262, United States
Pfizer Investigational Site
Tulsa, Oklahoma, 74104, United States
Pfizer Investigational Site
Cranberry Township, Pennsylvania, 16066, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15238, United States
Pfizer Investigational Site
Memphis, Tennessee, 38119, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Kenneth 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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2007
First Posted
March 1, 2007
Study Start
March 1, 2007
Primary Completion
February 1, 2008
Study Completion
July 1, 2008
Last Updated
September 14, 2020
Results First Posted
August 27, 2020
Record last verified: 2020-09