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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00595101
First received: January 4, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Primary Open Angle Glaucoma
Ocular Hypertension
Drug: PF-03187207
Drug: Latanoprost 0.005%
Drug: PF-03187207 Vehicle
Drug: Latanoprost Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Reduction in intraocular pressure (IOP) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
    Mean reduction in diurnal IOP from baseline on Day 28


Secondary Outcome Measures:
  • IOP level across scheduled time points [ Time Frame: Day 14 and Day 28 ] [ Designated as safety issue: No ]
  • Target IOP [ Time Frame: Over all visits through Day 28 ] [ Designated as safety issue: No ]
    Proportion of subjects with ≤ target IOPs across all measured time points.


Enrollment: 128
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03187207 High Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
Drug: PF-03187207 Drug: Latanoprost Vehicle
Experimental: Latanoprost 0.005% and PF-03187207 Vehicle
A single drop of each, once daily in study eye for 28 days
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.
Experimental: PF-03187207 Medium Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
Drug: PF-03187207 Drug: Latanoprost Vehicle
Experimental: PF-03187207 Low Dose and Latanoprost Vehicle
A single drop of each, once daily in study eye for 28 days
Drug: PF-03187207 Drug: Latanoprost Vehicle

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595101

Locations
Japan
Pfizer Investigational Site
Inbagun Suimachi, Chiba, Japan
Pfizer Investigational Site
Narashino, Chiba, Japan
Pfizer Investigational Site
Kawasaki, Kanagawa, Japan
Pfizer Investigational Site
Kasukabe, Saitama, Japan
Pfizer Investigational Site
Fuji, Shizuoka, Japan
Pfizer Investigational Site
Mishima, Shizuoka, Japan
Pfizer Investigational Site
Susono, Shizuoka, Japan
Pfizer Investigational Site
Hachioji, Tokyo, Japan
Pfizer Investigational Site
Hamura, Tokyo, Japan
Pfizer Investigational Site
Minato, Tokyo, Japan
Pfizer Investigational Site
Musashino, Tokyo, Japan
Pfizer Investigational Site
Setagaya, Tokyo, Japan
Pfizer Investigational Site
Shizuoka, Japan
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Ken Harper Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00595101     History of Changes
Other Study ID Numbers: A9441003
Study First Received: January 4, 2008
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014