A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00751127

Purpose

PhXA41 is not inferior to timolol

Condition	Intervention	Phase
PhXA41 Timolol Open Angle Glaucoma Ocular Hypertension	Drug: PhXA41 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 (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 6-Month, Randomized, Double-Masked Comparison of Latanoprost (PhXA41) With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-Centre Study in the United States.

Further study details as provided by Pfizer:

Primary Outcome Measures:

to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment. [ Time Frame: 6 mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups. [ Time Frame: 6 mos ] [ Designated as safety issue: No ]

Enrollment:	268
Study Start Date:	January 1993
Study Completion Date:	February 1994
Primary Completion Date:	February 1994 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Timolol: Active Comparator	Drug: timolol One drop in the affected eye twice daily for six months.
PhXA41: Experimental	Drug: PhXA41 One drop in the affected eye once daily for six months.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
Open angle glaucoma appearing more than 6 months after cataract surgery is recognized as primary open angle glaucoma. (individuals requiring treatment bilaterally must fulfill eligibility criteria for both eyes.)
IOP of 22mmHg or higher obtained during the pre-study period.
Patients currently not treated or on single-drug treatment for the elevated IOP are eligible after a medication free period (wash-out) of:
1. 3 weeks for B-adrenergic antagonists
2. 2 weeks for adrenergic agonists
3. 5 days for cholinergics and oral carbonic anhydrase inhibitors.

Exclusion Criteria:

History of acute angle closure.
Severe trauma at any time.
Intraocular surgery or argon laser trabeculoplasty within 6 months.
Current use of contact lenses.
History of severe dry eye syndrome.
Ocular inflammation/infection with three months of inclusion.
Any condition preventing reliable applanation tonometry.
Unacceptable finding at pre-study ocular examination as specified in the Case Report Forms.
In Investigator regards monotherapy insufficient with respect to optic nerve head and/or visual field status.
Treatment of elevated IOP with any topical B-adrenergic antagonist regularly for a period longer than 3 months and/or treatment at any time during 6 months prior to study start.
Cardiac failure, sinus bradycardia, second and third degree of atrio-ventricular block.
Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
Having participated in any other clinical study within the last month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751127

Locations

United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90033
Pfizer Investigational Site
La Jolla, California, United States, 92093-0946
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Kentucky
Pfizer Investigational Site
Louisville, Kentucky, United States, 40292
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21209
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68105
United States, New Jersey
Pfizer Investigational Site
River Edge, New Jersey, United States, 07661-1931
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
New York, New York, United States, 10003
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97210-3049
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107-5599
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425-0001
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53705-3611

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	9200PG004
Study First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751127
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

open angle glaucoma ocular hypertension

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 16, 2009