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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00572455
First received: December 11, 2007
Last updated: February 25, 2011
Last verified: February 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014