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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00595101

First Posted: January 16, 2008

Last Update Posted: December 13, 2013

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.

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

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 0.005% Drug: PF-03187207 Vehicle Drug: Latanoprost Vehicle	Phase 2


Study Type:	Interventional
Study Design:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Latanoprost

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	128
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Information from the National Library of Medicine

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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

Contacts and Locations

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

More Information


Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00595101 History of Changes
Other Study ID Numbers:	A9441003
First Submitted:	January 4, 2008
First Posted:	January 16, 2008
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

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