Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
A 2-STAGE, PHASE 2, DOUBLE-MASKED, RANDOMIZED, VEHICLE CONTROLLED, DOSE RESPONSE TRIAL OF PF-04217329 AND THE MARKETED FORMULATION OF LATANOPROST IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
1 other identifier
interventional
318
1 country
23
Brief Summary
To evaluate the safety and efficacy of PF-04217329.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2007
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2007
CompletedStudy Start
First participant enrolled
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2009
CompletedResults Posted
Study results publicly available
April 30, 2021
CompletedApril 30, 2021
April 1, 2021
1.5 years
December 11, 2007
April 6, 2021
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Stage I: Baseline, Day 14
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
Stage II: Baseline, Day 28
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
Secondary Outcomes (6)
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Stage I: Day 1 up to Day 14
- +1 more secondary outcomes
Study Arms (14)
Stage 1: PF-04217329 - Lowest Dose
EXPERIMENTALStage 1: PF-04217329 - Low Dose
EXPERIMENTALStage 1: PF-04217329 - Middle Dose
EXPERIMENTALStage 1: PF-04217329 - High Middle Dose
EXPERIMENTALStage 1: PF-04217329 - High Dose
EXPERIMENTALStage 1: PF-02417329 - Highest Dose
EXPERIMENTALStage 1: PF-04217329 - Vehicle
EXPERIMENTALStage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
EXPERIMENTALStage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
EXPERIMENTALStage 2: PF-04217329 - High Dose + Latanoprost Vehicle
EXPERIMENTALStage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
EXPERIMENTALStage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
EXPERIMENTALStage 2: PF-04217329 - High Dose + Latanoprost 0.005%
EXPERIMENTALStage 2: PF-04217329 - Vehicle + Latanoprost 0.005%
EXPERIMENTALInterventions
1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Eligibility Criteria
You may qualify if:
- Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
- Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.
You may not qualify if:
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
- Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (23)
Sall Research Medical Center
Artesia, California, 90701, United States
Eye Research Foundation
Newport Beach, California, 92663, United States
North Bay Eye Associates, Inc.
Petaluma, California, 94954, United States
Centre For Health Care
Poway, California, 92064, United States
Atlantic Institute of Clinical Research
Daytona Beach, Florida, 32114, United States
Florida Health Care Plans
Daytona Beach, Florida, 32114, United States
Eye Associates of Fort Myers
Fort Myers, Florida, 33901, United States
International Eye Associates, PA
Ormond Beach, Florida, 32174, United States
Coastal Research Associates,LLC
Atlanta, Georgia, 30339, United States
Omni Eye Services of Atlanta
Atlanta, Georgia, 30342, United States
Eye Care Centers Management, Inc.
Morrow, Georgia, 30260, United States
The Eye Group of Southern Indiana
Evansville, Indiana, 47710, United States
Taustine Eye Center
Louisville, Kentucky, 40217, United States
Rochester Ophthalmological Group, PC
Rochester, New York, 14618, United States
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte, North Carolina, 28210, United States
Cornerstone Eye Care
High Point, North Carolina, 27262, United States
Mark J. Weiss, MD. Inc.
Tulsa, Oklahoma, 74104, United States
Glaucoma Care Center at Century Eye Care
Bristol, Pennsylvania, 19007, United States
Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Bluestein Custom Vision
Charleston, South Carolina, 29414-5893, United States
Total Eye Care, PA
Memphis, Tennessee, 38119, United States
Texan Eye Care, PA
Austin, Texas, 78746, United States
Eye Physicians of Austin
Austin, Texas, 78756, United States
Related Publications (1)
Schachar RA, Raber S, Courtney R, Zhang M. A phase 2, randomized, dose-response trial of taprenepag isopropyl (PF-04217329) versus latanoprost 0.005% in open-angle glaucoma and ocular hypertension. Curr Eye Res. 2011 Sep;36(9):809-17. doi: 10.3109/02713683.2011.593725.
PMID: 21851167DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
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
December 11, 2007
First Posted
December 13, 2007
Study Start
December 11, 2007
Primary Completion
June 26, 2009
Study Completion
June 26, 2009
Last Updated
April 30, 2021
Results First Posted
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.