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

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	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:

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:

Reduction in intraocular pressure (IOP) at end of follow-up period [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IOP level across scheduled visits. [ Time Frame: 14 days and 28 days ] [ Designated as safety issue: No ]
Proportion of subjects with less than or equal to target IOPs across all measurement time points. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change in safety assessments throughout the study period. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Experimental: PF-03187207 High Dose N/A	Drug: PF-03187207 1 drop, once a day in each treated eye.
Experimental: PF-03187207 Low Dose N/A	Drug: PF-03187207 1 drop, once a day in each treated eye.
Experimental: PF-03187207 Middle Dose N/A	Drug: PF-03187207 1 drop, once a day in each treated eye.
Active Comparator: Latanoprost N/A	Drug: Latanoprost 1 drop, once a day in each treated eye.

Eligibility

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

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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer Inc.
ClinicalTrials.gov Identifier:	NCT00595101 History of Changes
Other Study ID Numbers:	A9441003
Study First Received:	January 4, 2008
Last Updated:	July 7, 2008
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 May 16, 2013