Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00934089
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Pfizer

Brief Summary:
This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: PF-04217329 Drug: latanoprost vehicle Drug: latanoprost Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Single-Masked, Randomized, Crossover Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329 Alone and In Combination With Latanoprost
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Latanoprost

Arm Intervention/treatment
Experimental: PF-04217329 + placebo
Active study drug + latanoprost vehicle
Drug: PF-04217329
Topical ocular solution, once-daily for 14 days

Drug: latanoprost vehicle
Topical ocular solution, once-daily for 14 days

Experimental: PF-04217329 + latanoprost
Active study drug + latanoprost
Drug: PF-04217329
Topical ocular solution, once-daily for 14 days

Drug: latanoprost
Topical ocular solution, once-daily for 14 days
Other Name: Xalatan




Primary Outcome Measures :
  1. Intraocular pressure (IOP) change from baseline [ Time Frame: 21 days ]
  2. Plasma concentrations of the active metabolite of PF-04217329 [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Diastolic ocular perfusion pressure and mean change from baseline [ Time Frame: 14 days ]
  2. Conjunctival hyperemia scores and change from baseline [ Time Frame: 35 days ]
  3. Corneal staining scores and mean change from baseline [ Time Frame: 35 days ]
  4. Mean corneal thickness change from baseline [ Time Frame: 35 days ]
  5. Mean change in corneal endothelial cell counts from baseline [ Time Frame: 35 days ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
  • Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
  • Visual acuity correctable to 20/100 or better in each eye.

Exclusion Criteria:

  • Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
  • Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
  • Advanced glaucoma or a history of severe central visual field loss in either eye.
  • History of ocular surgery or trauma in either eye within 6 months of the screening visit.
  • History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.

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): NCT00934089


Locations
Layout table for location information
United States, California
Pfizer Investigational Site
Cypress, California, United States, 90630
Pfizer Investigational Site
Garden Grove, California, United States, 92844
Pfizer Investigational Site
Gardena, California, United States, 90247
Pfizer Investigational Site
Long Beach, California, United States, 90806
Pfizer Investigational Site
Los Angeles, California, United States, 90013
Pfizer Investigational Site
Los Angeles, California, United States, 90057
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Pasadena, California, United States, 91105
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Layout table for additonal information
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00934089     History of Changes
Other Study ID Numbers: A0191002
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Layout table for MeSH terms
Ocular Hypertension
Glaucoma, Open-Angle
Glaucoma
Eye Diseases
Latanoprost
Antihypertensive Agents