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

To evaluate the safety and efficacy of PF-04217329.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-Angle Glaucoma
• Intervention / Treatment: Drug: PF-04217329 - Lowest Dose; Drug: PF-04217329 - Low Dose; Drug: PF-04217329 - Low Dose; Drug: PF-04217329 - Low Dose; Drug: PF-04217329 - Middle Dose; Drug: PF-04217329 - Middle Dose; Drug: PF-04217329 - Middle Dose; Drug: PF-04217329 - High Middle Dose; Drug: PF-04217329 - High Dose; Drug: PF-04217329 - High Dose; Drug: PF-04217329 - High Dose; Drug: PF-4217329 - Highest Dose; Drug: PF-04217329 - Vehicle; Drug: PF-04217329 - Vehicle; Drug: Latanoprost Vehicle; Drug: Latanoprost 0.005%

• Study Type: Interventional
• Enrollment (Actual): 318
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Sall Research Medical Center
    • Newport Beach, California, United States, 92663
      • Eye Research Foundation
    • Petaluma, California, United States, 94954
      • North Bay Eye Associates, Inc.
    • Poway, California, United States, 92064
      • Centre For Health Care
  • Florida
    • Daytona Beach, Florida, United States, 32114
      • Atlantic Institute of Clinical Research
    • Daytona Beach, Florida, United States, 32114
      • Florida Health Care Plans
    • Fort Myers, Florida, United States, 33901
      • Eye Associates of Fort Myers
    • Ormond Beach, Florida, United States, 32174
      • International Eye Associates, PA
  • Georgia
    • Atlanta, Georgia, United States, 30339
      • Coastal Research Associates,LLC
    • Atlanta, Georgia, United States, 30342
      • Omni Eye Services of Atlanta
    • Morrow, Georgia, United States, 30260
      • Eye Care Centers Management, Inc.
  • Indiana
    • Evansville, Indiana, United States, 47710
      • The Eye Group of Southern Indiana
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Taustine Eye Center
  • New York
    • Rochester, New York, United States, 14618
      • Rochester Ophthalmological Group, PC
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates, PA
    • High Point, North Carolina, United States, 27262
      • Cornerstone Eye Care
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Mark J. Weiss, MD. Inc.
  • Pennsylvania
    • Bristol, Pennsylvania, United States, 19007
      • Glaucoma Care Center at Century Eye Care
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Institute
  • South Carolina
    • Charleston, South Carolina, United States, 29414-5893
      • Bluestein Custom Vision
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, PA
  • Texas
    • Austin, Texas, United States, 78746
      • Texan Eye Care, PA
    • Austin, Texas, United States, 78756
      • Eye Physicians of Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: PF-04217329 - Lowest Dose	Drug: PF-04217329 - Lowest Dose; 1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
Experimental: Stage 1: PF-04217329 - Low Dose	Drug: PF-04217329 - Low Dose; 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Low Dose; Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Low Dose; Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
Experimental: Stage 1: PF-04217329 - Middle Dose	Drug: PF-04217329 - Middle Dose; 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Middle Dose; Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Middle Dose; Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
Experimental: Stage 1: PF-04217329 - High Middle Dose	Drug: PF-04217329 - High Middle Dose; 1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
Experimental: Stage 1: PF-04217329 - High Dose	Drug: PF-04217329 - High Dose; 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - High Dose; Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - High Dose; Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
Experimental: Stage 1: PF-02417329 - Highest Dose	Drug: PF-4217329 - Highest Dose; 1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
Experimental: Stage 1: PF-04217329 - Vehicle	Drug: PF-04217329 - Vehicle; 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Vehicle; Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle	Drug: PF-04217329 - Low Dose; 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Low Dose; Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Low Dose; Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: Latanoprost Vehicle; 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle	Drug: PF-04217329 - Middle Dose; 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Middle Dose; Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Middle Dose; Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: Latanoprost Vehicle; 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle	Drug: PF-04217329 - High Dose; 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - High Dose; Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - High Dose; Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: Latanoprost Vehicle; 1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%	Drug: PF-04217329 - Low Dose; 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Low Dose; Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Low Dose; Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: Latanoprost 0.005%; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%	Drug: PF-04217329 - Middle Dose; 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Middle Dose; Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Middle Dose; Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: Latanoprost 0.005%; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%	Drug: PF-04217329 - High Dose; 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - High Dose; Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - High Dose; Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.; Drug: Latanoprost 0.005%; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Experimental: Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%	Drug: PF-04217329 - Vehicle; 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.; Drug: PF-04217329 - Vehicle; Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.; Drug: Latanoprost 0.005%; 1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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).	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	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.	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	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).	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	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.	Stage I: Day 1 up to Day 14
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.	Stage II: Day 1 up to Day 28

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2007
• Primary Completion (Actual): June 26, 2009
• Study Completion (Actual): June 26, 2009

Study Registration Dates

• First Submitted: December 11, 2007
• First Submitted That Met QC Criteria: December 11, 2007
• First Posted (Estimate): December 13, 2007

Study Record Updates

• Last Update Posted (Actual): April 30, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Ocular Hypertension; Open-Angle Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: A0191001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.