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A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

Primary Purpose

Ocular Hypertension, Open Angle Glaucoma

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
timolol
PhXA41
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Hypertension 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PhXA41

timolol

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
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00751049
Brief Title
A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
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 the United Kingdom
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 1992 (undefined)
Primary Completion Date
December 1993 (Actual)
Study Completion Date
December 1993 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study PhXA41 for its non-inferiority compared with timolol in lowering intra-ocular pressure

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
294 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PhXA41
Arm Type
Experimental
Arm Title
timolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
timolol
Intervention Description
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
Intervention Type
Drug
Intervention Name(s)
PhXA41
Intervention Description
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
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
Aberdeen
State/Province
Grampian
ZIP/Postal Code
AB25 2ZD
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Nottingham
State/Province
Notts.
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cambridge
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Cardiff
ZIP/Postal Code
CF4 4XW
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Dundee
ZIP/Postal Code
DD2 9SY
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Paisley
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom

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=9200PG005&StudyName=A%20study%20of%20open%20angle%20glaucoma%20or%20ocular%20hypertension%20in%20patients%20within%20the%20United%20Kingdom.
Description
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A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom

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