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

Completed · Phase 3

Conditions studied: Glaucoma, Open Angle Glaucoma, Ocular Hypertension

In brief

PhXA41 is not inferior to timolol

Key facts

Study ID: NCT00751127
Run by: Pfizer
People needed: 268
Starts: 1993-01-01
Expected to finish: 1994-02-01
Last updated by the study team: 2011-03-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
3 weeks for B-adrenergic antagonists
2 weeks for adrenergic agonists
5 days for cholinergics and oral carbonic anhydrase inhibitors.

You may not qualify if…

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.

Where it is running

Pfizer Investigational Site — La Jolla, California, United States
Pfizer Investigational Site — Los Angeles, California, United States
Pfizer Investigational Site — Gainesville, Florida, United States
Pfizer Investigational Site — Chicago, Illinois, United States
Pfizer Investigational Site — Chicago, Illinois, United States
Pfizer Investigational Site — Louisville, Kentucky, United States
Pfizer Investigational Site — Baltimore, Maryland, United States
Pfizer Investigational Site — Ann Arbor, Michigan, United States
Pfizer Investigational Site — St Louis, Missouri, United States
Pfizer Investigational Site — Omaha, Nebraska, United States
Pfizer Investigational Site — River Edge, New Jersey, United States
Pfizer Investigational Site — New York, New York, United States
Pfizer Investigational Site — New York, New York, United States
Pfizer Investigational Site — Portland, Oregon, United States
Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
Pfizer Investigational Site — Charleston, South Carolina, United States
Pfizer Investigational Site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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