A Phase 2, Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma - Full Text View

Sponsors and Collaborators:	Pfizer NicOx Inc.
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00441883

Purpose

This study will evaluate the safety and efficacy of PF 03187207.

Condition	Intervention	Phase
Primary Open Angle Glaucoma Ocular Hypertension Pigmentary Glaucoma Pseudoexfoliative Glaucoma	Drug: PF-03187207 Drug: latanoprost	Phase II

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost

Further study details as provided by Pfizer:

Primary Outcome Measures:

Change in diurnal intraocular pressure (IOP) at day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in resting pulse and blood pressure, and clinical laboratories throughout the study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Determine the impact of dose timing [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Change from baseline IOP at the Day 7, 14, 21, and 28 visits [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Proportion of patients at target IOP across all study visits [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Change in safety assessments, ocular and systemic adverse events throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Change in refraction, visual acuity, visual fields throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Change in pupil diameter, biomicroscopic examination throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
Change in ophthalmoscopy, gonioscopy, pachymetry throughout study period [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	216
Study Start Date:	March 2007
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active: Active Comparator	Drug: latanoprost 1 drop, once a day, per dosed eye for duration of study.
Experimental: Experimental	Drug: PF-03187207 1 drop, once a day, per dosed eye for duration of study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man or woman at least 18 years of age
diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes

Exclusion Criteria:

-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441883

Locations

United States, California
Pfizer Investigational Site
Newport Beach, California, United States, 92663
Pfizer Investigational Site
Artesia, California, United States, 90701
Pfizer Investigational Site
Petaluma, California, United States, 94954
Pfizer Investigational Site
Poway, California, United States, 92064
United States, Connecticut
Pfizer Investigational Site
Danbury, Connecticut, United States, 06810-4004
United States, Florida
Pfizer Investigational Site
Ormond Beach, Florida, United States, 32174
Pfizer Investigational Site
Jacksonville, Florida, United States, 32204
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30339
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Indiana
Pfizer Investigational Site
Evansville, Indiana, United States, 47710
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, New York
Pfizer Investigational Site
Rochester, New York, United States, 14618
United States, North Carolina
Pfizer Investigational Site
High Point, North Carolina, United States, 27262
Pfizer Investigational Site
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Pfizer Investigational Site
Cranberry Township, Pennsylvania, United States, 16066
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15238
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705

Sponsors and Collaborators

Pfizer

NicOx Inc.

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

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

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9441001
Study First Received:	February 27, 2007
Last Updated:	April 8, 2008
ClinicalTrials.gov Identifier:	NCT00441883
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Glaucoma
Eye Diseases
Glaucoma, Open-Angle

Vascular Diseases
Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Therapeutic Uses
Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009