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

Purpose

To evaluate the safety and efficacy of PF-04217329.

Condition	Intervention	Phase
Primary Open Angle Glaucoma Ocular Hypertension	Drug: PF-04217329 - Lowest Dose Drug: PF-04217329 - Low Dose Drug: PF-04217329 - Middle Dose Drug: PF-04217329 - High Middle Dose Drug: PF-04217329 - High Dose Drug: PF-4217329 - Highest Dose Drug: PF-04217329 - Vehicle Drug: Latanoprost Vehicle Drug: Latanoprost 0.005%	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Mean diurnal intraocular pressure (IOP) change from baseline in the study eye at the Day 14 Visit (Stage 1) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Mean diurnal intraocular pressure (IOP) change from baseline in the study eye at the Day 28 Visit (Stage 2) [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients reaching a target intraocular pressure (IOP) across study visits. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Mean intraocular pressure (IOP) value and its change from baseline in the study eye across study visits. [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Proportion of patients reaching a target intraocular pressure (IOP) across study visits (Stage 2). [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Mean intraocular pressure (IOP) value and its change from baseline in the study eye across study visits. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment:	317
Study Start Date:	December 2007
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.
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.
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.
Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle	Drug: Latanoprost Vehicle 1 drop of latanoprost vehicle, 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.
Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle	Drug: Latanoprost Vehicle 1 drop of latanoprost vehicle, 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.
Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle	Drug: Latanoprost Vehicle 1 drop of latanoprost vehicle, 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.
Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%	Drug: Latanoprost 0.005% 1 drop of latanoprost 0.005%, 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 2: PF-04217329 - Middle Dose + Latanoprost 0.005%	Drug: Latanoprost 0.005% 1 drop of latanoprost 0.005%, 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 2: PF-04217329 - High Dose + Latanoprost 0.005%	Drug: Latanoprost 0.005% 1 drop of latanoprost 0.005%, 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 2: PF-04217329 - Vehicle + Latanoprost 0.005%	Drug: Latanoprost 0.005% 1 drop of latanoprost 0.005%, 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572455

Locations

United States, California
Pfizer Investigational Site
Artesia, California, United States, 90701
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Petaluma, California, United States, 94954
Pfizer Investigational Site
Poway, California, United States, 92064
United States, Florida
Pfizer Investigational Site
Daytona Beach, Florida, United States, 32114
Pfizer Investigational Site
Fort Myers, Florida, United States, 33901
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
Pfizer Investigational Site
Morrow, Georgia, United States, 30260
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47710
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site
High Point, North Carolina, United States, 27262
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Pfizer Investigational Site
Bristol, Pennsylvania, United States, 19007
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29414-5893
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78746
Pfizer Investigational Site
Austin, Texas, United States, 78756

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier:	NCT00572455 History of Changes
Other Study ID Numbers:	A0191001
Study First Received:	December 11, 2007
Last Updated:	February 25, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Open-Angle Glaucoma
Ocular Hypertension

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases

Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013