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

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NCT00572455

Last updated on December 5, 2019
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Artesia, California, 90701 United States
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Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Primary Open Angle Glaucoma, Ocular Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00572455
Pfizer
Completed
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

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Descriptive Information
Brief Title  ICMJE Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Official Title  ICMJE 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.
Brief SummaryTo evaluate the safety and efficacy of PF-04217329.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Open Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: PF-04217329 - Lowest Dose
    1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
  • 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 - Middle Dose
    1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - High Middle Dose
    1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - High Dose
    1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-4217329 - Highest Dose
    1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
  • Drug: PF-04217329 - Vehicle
    1 drop of PF-04217329 vehicle, 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.
  • 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 - 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 - 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: 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.
  • 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: 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: 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.
Study Arms  ICMJE
  • Experimental: Stage 1: PF-04217329 - Lowest Dose
    Intervention: Drug: PF-04217329 - Lowest Dose
  • Experimental: Stage 1: PF-04217329 - Low Dose
    Intervention: Drug: PF-04217329 - Low Dose
  • Experimental: Stage 1: PF-04217329 - Middle Dose
    Intervention: Drug: PF-04217329 - Middle Dose
  • Experimental: Stage 1: PF-04217329 - High Middle Dose
    Intervention: Drug: PF-04217329 - High Middle Dose
  • Experimental: Stage 1: PF-04217329 - High Dose
    Intervention: Drug: PF-04217329 - High Dose
  • Experimental: Stage 1: PF-02417329 - Highest Dose
    Intervention: Drug: PF-4217329 - Highest Dose
  • Experimental: Stage 1: PF-04217329 - Vehicle
    Intervention: Drug: PF-04217329 - Vehicle
  • Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
    Interventions:
    • Drug: Latanoprost Vehicle
    • Drug: PF-04217329 - Low Dose
  • Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
    Interventions:
    • Drug: Latanoprost Vehicle
    • Drug: PF-04217329 - Middle Dose
  • Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle
    Interventions:
    • Drug: Latanoprost Vehicle
    • Drug: PF-04217329 - High Dose
  • Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - Low Dose
  • Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - Middle Dose
  • Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - High Dose
  • Experimental: Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%
    Interventions:
    • Drug: Latanoprost 0.005%
    • Drug: PF-04217329 - Vehicle
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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2011)		317
Original Enrollment  ICMJE
 (submitted: December 11, 2007)		256
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion DateJune 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00572455
Other Study ID Numbers  ICMJE A0191001
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateFebruary 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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