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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00934089

Purpose

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	Intervention	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: PF-04217329 Drug: latanoprost vehicle Drug: latanoprost	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) 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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Intraocular pressure (IOP) change from baseline [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Plasma concentrations of the active metabolite of PF-04217329 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Diastolic ocular perfusion pressure and mean change from baseline [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Conjunctival hyperemia scores and change from baseline [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
Corneal staining scores and mean change from baseline [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
Mean corneal thickness change from baseline [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
Mean change in corneal endothelial cell counts from baseline [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]

Enrollment:	31
Study Start Date:	January 2010
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00934089

Locations

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, 90057
Pfizer Investigational Site
Los Angeles, California, United States, 90013
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Pasadena, California, United States, 91105

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00934089 History of Changes
Other Study ID Numbers:	A0191002
Study First Received:	July 6, 2009
Last Updated:	June 28, 2011
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 February 09, 2012