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

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ClinicalTrials.gov Identifier: NCT00595101
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : December 13, 2013
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : December 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
Drug Information available for: Latanoprost
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Reduction in intraocular pressure (IOP) [ Time Frame: Day 28 ]
    Mean reduction in diurnal IOP from baseline on Day 28


Secondary Outcome Measures :
  1. IOP level across scheduled time points [ Time Frame: Day 14 and Day 28 ]
  2. Target IOP [ Time Frame: Over all visits through Day 28 ]
    Proportion of subjects with ≤ target IOPs across all measured time points.



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT00595101     History of Changes
Other Study ID Numbers: A9441003
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: December 13, 2013
Last Verified: November 2013

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