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

Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751127
• Other study ID #: 9200PG004
• Status: Completed
• Phase: Phase 3
• First received: September 10, 2008
• Last updated: March 24, 2011
• Start date: January 1993
• Est. completion date: February 1994

Study information

• Verified date: September 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

PhXA41 is not inferior to timolol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 268
• Est. completion date: February 1994
• Est. primary completion date: February 1994
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• PhXA41
One drop in the affected eye once daily for six months.
• timolol
One drop in the affected eye twice daily for six months.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment.		6 mos	No
Secondary	to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.		6 mos	No

External Links

•   To obtain contact information for a study center near you, click here.