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

Primary Purpose

Glaucoma, Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
PhXA41
timolol
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring open angle glaucoma, ocular hypertension

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Timolol

PhXA41

Arm Description

Outcomes

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.

Secondary Outcome Measures

to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.

Full Information

First Posted
September 10, 2008
Last Updated
March 24, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00751127
Brief Title
A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
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 Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
January 1993 (undefined)
Primary Completion Date
February 1994 (Actual)
Study Completion Date
February 1994 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
PhXA41 is not inferior to timolol

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open Angle Glaucoma, Ocular Hypertension
Keywords
open angle glaucoma, ocular hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
268 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Timolol
Arm Type
Active Comparator
Arm Title
PhXA41
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PhXA41
Intervention Description
One drop in the affected eye once daily for six months.
Intervention Type
Drug
Intervention Name(s)
timolol
Intervention Description
One drop in the affected eye twice daily for six months.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.
Time Frame
6 mos

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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: 3 weeks for B-adrenergic antagonists 2 weeks for adrenergic agonists 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0946
Country
United States
Facility Name
Pfizer Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Pfizer Investigational Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Pfizer Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40292
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
Facility Name
Pfizer Investigational Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States
Facility Name
Pfizer Investigational Site
City
River Edge
State/Province
New Jersey
ZIP/Postal Code
07661-1931
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210-3049
Country
United States
Facility Name
Pfizer Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107-5599
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0001
Country
United States
Facility Name
Pfizer Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705-3611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19427617
Citation
Varma R, Hwang LJ, Grunden JW, Bean GW, Sultan MB. Assessing the efficacy of latanoprost vs timolol using an alternate efficacy parameter: the intervisit intraocular pressure range. Am J Ophthalmol. 2009 Aug;148(2):221-6. doi: 10.1016/j.ajo.2009.02.035. Epub 2009 May 9.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=9200PG004&StudyName=A%206%20month%20study%20comparing%20latanoprost%20with%20timolol%20in%20patients%20with%20open%20angle%20glauocma%20or%20ocular%20hypertension
Description
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A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension

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