A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2008

Interventions

  • Drug: PF-03187207
  • Drug: Latanoprost 0.005%
  • Drug: PF-03187207 Vehicle
    • One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.
  • Drug: Latanoprost Vehicle

Arms, Groups and Cohorts

  • Experimental: PF-03187207 High Dose and Latanoprost Vehicle
    • A single drop of each, once daily in study eye for 28 days
  • Experimental: Latanoprost 0.005% and PF-03187207 Vehicle
    • A single drop of each, once daily in study eye for 28 days
  • Experimental: PF-03187207 Medium Dose and Latanoprost Vehicle
    • A single drop of each, once daily in study eye for 28 days
  • Experimental: PF-03187207 Low Dose and Latanoprost Vehicle
    • A single drop of each, once daily in study eye for 28 days

Clinical Trial Outcome Measures

Primary Measures

  • Reduction in intraocular pressure (IOP)
    • Time Frame: Day 28
    • Mean reduction in diurnal IOP from baseline on Day 28

Secondary Measures

  • IOP level across scheduled time points
    • Time Frame: Day 14 and Day 28
  • Target IOP
    • Time Frame: Over all visits through Day 28
    • Proportion of subjects with ≤ target IOPs across all measured time points.

Participating in This Clinical Trial

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: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ken Harper, Study Director, Bausch & Lomb Incorporated

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