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Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

Primary Purpose

Primary Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PF-04217329 - Lowest Dose
PF-04217329 - Low Dose
PF-04217329 - Middle Dose
PF-04217329 - High Middle Dose
PF-04217329 - High Dose
PF-4217329 - Highest Dose
PF-04217329 - Vehicle
Latanoprost Vehicle
PF-04217329 - Low Dose
Latanoprost Vehicle
PF-04217329 - Middle Dose
Latanoprost Vehicle
PF-04217329 - High Dose
Latanoprost 0.005%
PF-04217329 - Low Dose
Latanoprost 0.005%
PF-04217329 - Middle Dose
Latanoprost 0.005%
PF-04217329 - High Dose
Latanoprost 0.005%
PF-04217329 - Vehicle
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open-Angle Glaucoma focused on measuring Open-Angle Glaucoma, Ocular Hypertension

Eligibility Criteria

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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Sall Research Medical Center
  • Eye Research Foundation
  • North Bay Eye Associates, Inc.
  • Centre For Health Care
  • Atlantic Institute of Clinical Research
  • Florida Health Care Plans
  • Eye Associates of Fort Myers
  • International Eye Associates, PA
  • Coastal Research Associates,LLC
  • Omni Eye Services of Atlanta
  • Eye Care Centers Management, Inc.
  • The Eye Group of Southern Indiana
  • Taustine Eye Center
  • Rochester Ophthalmological Group, PC
  • Charlotte Eye Ear Nose and Throat Associates, PA
  • Cornerstone Eye Care
  • Mark J. Weiss, MD. Inc.
  • Glaucoma Care Center at Century Eye Care
  • Wills Eye Institute
  • Bluestein Custom Vision
  • Total Eye Care, PA
  • Texan Eye Care, PA
  • Eye Physicians of Austin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Stage 1: PF-04217329 - Lowest Dose

Stage 1: PF-04217329 - Low Dose

Stage 1: PF-04217329 - Middle Dose

Stage 1: PF-04217329 - High Middle Dose

Stage 1: PF-04217329 - High Dose

Stage 1: PF-02417329 - Highest Dose

Stage 1: PF-04217329 - Vehicle

Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle

Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle

Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle

Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%

Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%

Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%

Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
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 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
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both 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 = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
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 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
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both 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 = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Percentage of participants who reached an IOP of less than or equal to (<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Percentage of participants who reached an IOP <= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.

Full Information

First Posted
December 11, 2007
Last Updated
April 6, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00572455
Brief Title
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 11, 2007 (Actual)
Primary Completion Date
June 26, 2009 (Actual)
Study Completion Date
June 26, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and efficacy of PF-04217329.

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
Keywords
Open-Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
318 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stage 1: PF-04217329 - Lowest Dose
Arm Type
Experimental
Arm Title
Stage 1: PF-04217329 - Low Dose
Arm Type
Experimental
Arm Title
Stage 1: PF-04217329 - Middle Dose
Arm Type
Experimental
Arm Title
Stage 1: PF-04217329 - High Middle Dose
Arm Type
Experimental
Arm Title
Stage 1: PF-04217329 - High Dose
Arm Type
Experimental
Arm Title
Stage 1: PF-02417329 - Highest Dose
Arm Type
Experimental
Arm Title
Stage 1: PF-04217329 - Vehicle
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%
Arm Type
Experimental
Arm Title
Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Lowest Dose
Intervention Description
1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Low Dose
Intervention Description
1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Middle Dose
Intervention Description
1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - High Middle Dose
Intervention Description
1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - High Dose
Intervention Description
1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-4217329 - Highest Dose
Intervention Description
1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Vehicle
Intervention Description
1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost Vehicle
Intervention Description
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Low Dose
Intervention Description
Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost Vehicle
Intervention Description
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Middle Dose
Intervention Description
Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost Vehicle
Intervention Description
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - High Dose
Intervention Description
Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Intervention Description
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Low Dose
Intervention Description
Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Intervention Description
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Middle Dose
Intervention Description
Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Intervention Description
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - High Dose
Intervention Description
Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
Latanoprost 0.005%
Intervention Description
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Intervention Type
Drug
Intervention Name(s)
PF-04217329 - Vehicle
Intervention Description
Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Description
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.
Time Frame
Stage I: Baseline, Day 14
Title
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Description
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.
Time Frame
Stage II: Baseline, Day 28
Title
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
Description
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.
Time Frame
Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
Title
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
Description
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.
Time Frame
Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
Secondary Outcome Measure Information:
Title
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
Description
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.
Time Frame
Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Title
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
Description
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both 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 = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
Time Frame
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
Title
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
Description
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.
Time Frame
Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Title
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
Description
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both 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 = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
Time Frame
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
Title
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Description
Percentage of participants who reached an IOP of less than or equal to (<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
Time Frame
Stage I: Day 1 up to Day 14
Title
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Description
Percentage of participants who reached an IOP <= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
Time Frame
Stage II: Day 1 up to Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Sall Research Medical Center
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Eye Research Foundation
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
North Bay Eye Associates, Inc.
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Centre For Health Care
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Atlantic Institute of Clinical Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Florida Health Care Plans
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Eye Associates of Fort Myers
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
International Eye Associates, PA
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Coastal Research Associates,LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Omni Eye Services of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Eye Care Centers Management, Inc.
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
The Eye Group of Southern Indiana
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
Facility Name
Taustine Eye Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Rochester Ophthalmological Group, PC
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates, PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cornerstone Eye Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Mark J. Weiss, MD. Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Glaucoma Care Center at Century Eye Care
City
Bristol
State/Province
Pennsylvania
ZIP/Postal Code
19007
Country
United States
Facility Name
Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Bluestein Custom Vision
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414-5893
Country
United States
Facility Name
Total Eye Care, PA
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Texan Eye Care, PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78746
Country
United States
Facility Name
Eye Physicians of Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
21851167
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0191001&StudyName=Safety%20and%20efficacy%20of%20PF-04217329%20in%20patients%20with%20glaucoma%20or%20elevated%20eye%20pressure.
Description
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Learn more about this trial

Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

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