A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma; Open Angle Glaucoma; Ocular Hypertension
Intervention: PhXA41 (Drug); timolol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
PhXA41 is not inferior to timolol
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.
Secondary outcome: to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, La Jolla, California 92093-0946, United States
Pfizer Investigational Site, Los Angeles, California 90033, United States
Pfizer Investigational Site, Gainesville, Florida 32610, United States
Pfizer Investigational Site, Chicago, Illinois 60611, United States
Pfizer Investigational Site, Chicago, Illinois 60612, United States
Pfizer Investigational Site, Louisville, Kentucky 40292, United States
Pfizer Investigational Site, Baltimore, Maryland 21209, United States
Pfizer Investigational Site, Ann Arbor, Michigan, United States
Pfizer Investigational Site, St. Louis, Missouri 63110, United States
Pfizer Investigational Site, Omaha, Nebraska 68105, United States
Pfizer Investigational Site, River Edge, New Jersey 07661-1931, United States
Pfizer Investigational Site, New York, New York 10003, United States
Pfizer Investigational Site, New York, New York 10029, United States
Pfizer Investigational Site, Portland, Oregon 97210-3049, United States
Pfizer Investigational Site, Philadelphia, Pennsylvania 19107-5599, United States
Pfizer Investigational Site, Charleston, South Carolina 29425-0001, United States
Pfizer Investigational Site, Madison, Wisconsin 53705-3611, United States
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 1993
Last updated: March 24, 2011
|
