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

NCT ID: NCT00572455

Last Updated: 2021-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

318 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-11

Study Completion Date

2009-06-26

Brief Summary

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To evaluate the safety and efficacy of PF-04217329.

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Detailed Description

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Conditions

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Primary Open-Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Stage 1: PF-04217329 - Lowest Dose

Group Type EXPERIMENTAL

PF-04217329 - Lowest Dose

Intervention Type DRUG

1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.

Stage 1: PF-04217329 - Low Dose

Group Type EXPERIMENTAL

PF-04217329 - Low Dose

Intervention Type DRUG

1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

Stage 1: PF-04217329 - Middle Dose

Group Type EXPERIMENTAL

PF-04217329 - Middle Dose

Intervention Type DRUG

1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.

Stage 1: PF-04217329 - High Middle Dose

Group Type EXPERIMENTAL

PF-04217329 - High Middle Dose

Intervention Type DRUG

1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.

Stage 1: PF-04217329 - High Dose

Group Type EXPERIMENTAL

PF-04217329 - High Dose

Intervention Type DRUG

1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.

Stage 1: PF-02417329 - Highest Dose

Group Type EXPERIMENTAL

PF-4217329 - Highest Dose

Intervention Type DRUG

1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.

Stage 1: PF-04217329 - Vehicle

Group Type EXPERIMENTAL

PF-04217329 - Vehicle

Intervention Type DRUG

1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost Vehicle

Intervention Type DRUG

1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

PF-04217329 - Low Dose

Intervention Type DRUG

Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost Vehicle

Intervention Type DRUG

1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

PF-04217329 - Middle Dose

Intervention Type DRUG

Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost Vehicle

Intervention Type DRUG

1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

PF-04217329 - High Dose

Intervention Type DRUG

Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost 0.005%

Intervention Type DRUG

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

PF-04217329 - Low Dose

Intervention Type DRUG

Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost 0.005%

Intervention Type DRUG

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

PF-04217329 - Middle Dose

Intervention Type DRUG

Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost 0.005%

Intervention Type DRUG

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

PF-04217329 - High Dose

Intervention Type DRUG

Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.

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

Group Type EXPERIMENTAL

Latanoprost 0.005%

Intervention Type DRUG

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

PF-04217329 - Vehicle

Intervention Type DRUG

Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.

Interventions

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PF-04217329 - Lowest Dose

1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.

Intervention Type DRUG

PF-04217329 - Low Dose

1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

Intervention Type DRUG

PF-04217329 - Middle Dose

1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.

Intervention Type DRUG

PF-04217329 - High Middle Dose

1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.

Intervention Type DRUG

PF-04217329 - High Dose

1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.

Intervention Type DRUG

PF-4217329 - Highest Dose

1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.

Intervention Type DRUG

PF-04217329 - Vehicle

1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.

Intervention Type DRUG

Latanoprost Vehicle

1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Latanoprost Vehicle

1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Latanoprost Vehicle

1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Latanoprost 0.005%

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Latanoprost 0.005%

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Latanoprost 0.005%

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Latanoprost 0.005%

1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Texan Eye Care, PA

Austin, Texas, United States

Site Status

Eye Physicians of Austin

Austin, Texas, United States

Site Status

Sall Research Medical Center

Artesia, California, United States

Site Status

Eye Research Foundation

Newport Beach, California, United States

Site Status

North Bay Eye Associates, Inc.

Petaluma, California, United States

Site Status

Centre For Health Care

Poway, California, United States

Site Status

Atlantic Institute of Clinical Research

Daytona Beach, Florida, United States

Site Status

Florida Health Care Plans

Daytona Beach, Florida, United States

Site Status

Eye Associates of Fort Myers

Fort Myers, Florida, United States

Site Status

International Eye Associates, PA

Ormond Beach, Florida, United States

Site Status

Coastal Research Associates,LLC

Atlanta, Georgia, United States

Site Status

Omni Eye Services of Atlanta

Atlanta, Georgia, United States

Site Status

Eye Care Centers Management, Inc.

Morrow, Georgia, United States

Site Status

The Eye Group of Southern Indiana

Evansville, Indiana, United States

Site Status

Taustine Eye Center

Louisville, Kentucky, United States

Site Status

Rochester Ophthalmological Group, PC

Rochester, New York, United States

Site Status

Charlotte Eye Ear Nose and Throat Associates, PA

Charlotte, North Carolina, United States

Site Status

Cornerstone Eye Care

High Point, North Carolina, United States

Site Status

Mark J. Weiss, MD. Inc.

Tulsa, Oklahoma, United States

Site Status

Glaucoma Care Center at Century Eye Care

Bristol, Pennsylvania, United States

Site Status

Wills Eye Institute

Philadelphia, Pennsylvania, United States

Site Status

Bluestein Custom Vision

Charleston, South Carolina, United States

Site Status

Total Eye Care, PA

Memphis, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21851167 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0191001&StudyName=Safety%20and%20efficacy%20of%20PF-04217329%20in%20patients%20with%20glaucoma%20or%20elevated%20eye%20pressure.

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

Other Identifiers

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A0191001

Identifier Type: -

Identifier Source: org_study_id

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