A Phase 2, Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

Official Title: “A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost”

This study will evaluate the safety and efficacy of PF 03187207.

Intervention(s) in this Clinical Trial

• Drug: PF-03187207
  • 1 drop, once a day, per dosed eye for duration of study.
• Drug: latanoprost
  • 1 drop, once a day, per dosed eye for duration of study.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Active
• Experimental: Experimental

Primary Measures

• Change in diurnal intraocular pressure (IOP) at day 28
  • Time Frame: 28 days
    Safety Issue?: No

Secondary Measures

• Change in resting pulse and blood pressure, and clinical laboratories throughout the study period
  • Time Frame: 28 days
    Safety Issue?: Yes
• Determine the impact of dose timing
  • Time Frame: 28 days
    Safety Issue?: Yes
• Change from baseline IOP at the Day 7, 14, 21, and 28 visits
  • Time Frame: 28 days
    Safety Issue?: Yes
• Proportion of patients at target IOP across all study visits
  • Time Frame: 28 days
    Safety Issue?: Yes
• Change in safety assessments, ocular and systemic adverse events throughout study period
  • Time Frame: 28 days
    Safety Issue?: Yes
• Change in refraction, visual acuity, visual fields throughout study period
  • Time Frame: 28 days
    Safety Issue?: Yes
• Change in pupil diameter, biomicroscopic examination throughout study period
  • Time Frame: 28 days
    Safety Issue?: Yes
• Change in ophthalmoscopy, gonioscopy, pachymetry throughout study period
  • Time Frame: 28 days
    Safety Issue?: Yes

Inclusion Criteria:

• Man or woman at least 18 years of age
• diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes

Exclusion Criteria:

• Closed or barely open anterior chamber angle or a history of acute angle closure in either eye

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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00441883

Study ID Number: A9441001

ClinicalTrials.gov Identifier: NCT00441883

Health Authority: United States: Food and Drug Administration

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