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

Verified by: Pfizer, February 2011
First Received: December 11, 2007 | Last Updated: February 25, 2011 | Phase: Phase 2 | Start Date: December 2007
Overall Status: Completed | Estimated Enrollment: 317
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To evaluate the safety and efficacy of PF-04217329...

Brief Summary

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.”

To evaluate the safety and efficacy of PF-04217329.

  • 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
  • Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

  • 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: 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.
  • 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.
  • 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: 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.
  • 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.
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Stage 1: PF-04217329 - Lowest Dose
  • Experimental: Stage 1: PF-04217329 - Low Dose
  • Experimental: Stage 1: PF-04217329 - Middle Dose
  • Experimental: Stage 1: PF-04217329 - High Middle Dose
  • Experimental: Stage 1: PF-04217329 - High Dose
  • Experimental: Stage 1: PF-02417329 - Highest Dose
  • Experimental: Stage 1: PF-04217329 - Vehicle
  • Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle
  • Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle
  • Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle
  • Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%
  • Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%
  • Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%
  • Experimental: Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean diurnal intraocular pressure (IOP) change from baseline in the study eye at the Day 14 Visit (Stage 1)
    • Time Frame: 14 days
      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
      Safety Issue?: No

Secondary Measures

  • Proportion of patients reaching a target intraocular pressure (IOP) across study visits.
    • Time Frame: 14 days
      Safety Issue?: No
  • Mean intraocular pressure (IOP) value and its change from baseline in the study eye across study visits.
    • Time Frame: 14 days
      Safety Issue?: No
  • Proportion of patients reaching a target intraocular pressure (IOP) across study visits (Stage 2).
    • Time Frame: 28 days
      Safety Issue?: No
  • Mean intraocular pressure (IOP) value and its change from baseline in the study eye across study visits.
    • Time Frame: 28 days
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00572455

Study ID Number: A0191001

ClinicalTrials.gov Identifier: NCT00572455

Health Authority: United States: Food and Drug Administration

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

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