A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Evening Dosing With Xalacom In Subjects With Glaucoma

This study has been completed.

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00159653

Purpose

To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.

Condition	Intervention	Phase
Glaucoma, Open-Angle Ocular Hypertension	Drug: Xalacom Drug: Xalatan Drug: Timolol	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Latanoprost Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension.

Further study details as provided by Pfizer:

Primary Outcome Measures:

The mean IOP measurements obtained in the study eye at each time point

Estimated Enrollment:	528
Study Start Date:	July 2005

Eligibility

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

Criteria

Inclusion Criteria:

Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria:

Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159653

Show 55 Study Locations

Sponsors and Collaborators

Pfizer

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

Study ID Numbers:	A6641027
Study First Received:	September 8, 2005
Last Updated:	September 5, 2007
ClinicalTrials.gov Identifier:	NCT00159653
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Glaucoma, Open-Angle
Vascular Diseases

Timolol
Latanoprost
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adrenergic beta-Antagonists

Adrenergic Antagonists
Cardiovascular Diseases
Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009