A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia - Full Text View

Purpose

PhXA41 is not inferior to timolol in reducing intra-ocular pressure

Condition	Intervention	Phase
Open Angle Glaucoma Ocular Hypertension	Drug: timolol Drug: PhXA41	Phase III

Genetics Home Reference related topics:

early-onset glaucoma

MedlinePlus related topics:

Glaucoma High Blood Pressure

ChemIDplus related topics:

Latanoprost Timolol Timolol maleate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Official Title:	A 6-Month, Randomized, Double-Masked Comparison of PhXA41 With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension. A Multi-Centre Study in Scandinavia

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 demonstrate the IOP-reducing effect of PhXA41 administered in the morning is equivalent the effect of PhXA41 administered in the evening [ Time Frame: 6 mos ] [ Designated as safety issue: No ]

Enrollment:	267
Study Start Date:	November 1992
Study Completion Date:	December 1993
Primary Completion Date:	December 1993 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Timolol: Active Comparator	Drug: timolol One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
PhXA41: Experimental	Drug: PhXA41 One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

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.

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: NCT00751062

Locations


Denmark
	Pfizer Investigational Site
	Hellerup, Denmark
	Pfizer Investigational Site
	Vejle, Denmark

Finland
	Pfizer Investigational Site
	Oulu, Finland

Norway
	Pfizer Investigational Site
	Trondheim, Norway
	Pfizer Investigational Site
	Oslo, Norway
	Pfizer Investigational Site
	Bergen, Norway

Sweden
	Pfizer Investigational Site
	Uppsala, Sweden
	Pfizer Investigational Site
	Huddinge, Sweden, 141 86
	Pfizer Investigational Site
	Linkoping, Sweden, 581 85
	Pfizer Investigational Site
	Lund, Sweden
	Pfizer Investigational Site
	Malmo, Sweden, 205 02
	Pfizer Investigational Site
	Umea, Sweden
	Pfizer Investigational Site
	Gothenburg, Sweden

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:	9200PG006, A6111130
First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751062
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 October 06, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00751062