Official Title: “A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.”

To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: PF-03187207
  • 1 drop, once a day in each treated eye.
• Drug: Latanoprost
  • 1 drop, once a day in each treated eye.
• Drug: PF-03187207
  • 1 drop, once a day in each treated eye.
• Drug: PF-03187207
  • 1 drop, once a day in each treated eye.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: PF-03187207 High Dose
  • N/A
• Experimental: PF-03187207 Low Dose
  • N/A
• Experimental: PF-03187207 Middle Dose
  • N/A
• Active Comparator: Latanoprost
  • N/A

Primary Measures

• Reduction in intraocular pressure (IOP) at end of follow-up period
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• IOP level across scheduled visits.
  • Time Frame: 14 days and 28 days
    Safety Issue?: No
• Proportion of subjects with less than or equal to target IOPs across all measurement time points.
  • Time Frame: 28 days
    Safety Issue?: No
• Change in safety assessments throughout the study period.
  • Time Frame: 28 days
    Safety Issue?: Yes

Inclusion Criteria:

• Man or woman at least 20 years of age
• Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.

Exclusion Criteria:

• Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
• Contraindications to latanoprost and nitric oxide treatment
• Known latanoprost non-responders

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 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  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00595101

Study ID Number: A9441003

ClinicalTrials.gov Identifier: NCT00595101

Health Authority: United States: Food and Drug Administration

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