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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: PF-04217329--High Dose
  • 1 drop of high 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--Medium Dose
  • 1 drop of medium dose PF-04217329, once a day, per dosed eye for duration of study.
• Drug: Xalatan
  • 1 drop, once a day, per dosed eye for duration of study.
• Drug: vehicle
  • 1 drop, once a day, per dosed eye for duration of study (stage 1 only)
• Drug: High Dose PF-04217329 and Xalatan
  • 1 drop each of high dose PF-04217329 and Xalatan, once a day, per dosed eye for duration of study.
• Drug: Low Dose PF-04217329 and Xalatan
  • 1 drop each of low dose PF-04217329 and Xalatan, once a day, per dosed eye for duration of study.
• Drug: Medium Dose PF-04217329 and Xalatan
  • 1 drop each of medium dose PF-04217329 and Xalatan, once a day, per dosed eye for duration of study.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: PF-04217329
• Active Comparator: Xalatan
• Other: Vehicle for Drug
  • Vehicle
• Experimental: PF-04217329 and Xalatan

Primary Measures

• Mean diurnal IOP (intraocular pressure) change from baseline in the study eye at the Day 14 Visit (Stage 1)
  • Time Frame: 14 days
    Safety Issue?: No
• Evaluation of ocular and systemic safety assessments throughout the study period (Stage 1)
  • Time Frame: 14 days
    Safety Issue?: Yes
• Mean diurnal IOP (intraocular pressure) 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 IOP across study visits.
  • Time Frame: 14 days
    Safety Issue?: No
• Mean IOP value and its change from baseline in the study eye across study visits.
  • Time Frame: 14 days
    Safety Issue?: No
• Evaluation of ocular and systemic safety assessments throughout the study period (Stage 2)
  • Time Frame: 28 days
    Safety Issue?: Yes
• Proportion of patients reaching a target IOP across study visits (Stage 2)
  • Time Frame: 28 days
    Safety Issue?: No
• Mean IOP value and its change from baseline in the study eye across study visits.
  • Time Frame: 28 days
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
• Qualifying 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 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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Overall Contact: Pfizer CT.gov Call Center 1-800-718-1021 

Information obtained from ClinicalTrials.gov on July 02, 2009

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

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