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

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

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Drug: PhXA41; Drug: timolol

• Study Type: Interventional
• Enrollment (Actual): 294
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Bristol, United Kingdom, BS1 2LX
    • Pfizer Investigational Site
  • Cambridge, United Kingdom
    • Pfizer Investigational Site
  • Cardiff, United Kingdom, CF4 4XW
    • Pfizer Investigational Site
  • Dundee, United Kingdom, DD2 9SY
    • Pfizer Investigational Site
  • Liverpool, United Kingdom, L7 8XP
    • Pfizer Investigational Site
  • London, United Kingdom, NW3 2QG
    • Pfizer Investigational Site
  • London, United Kingdom
    • Pfizer Investigational Site
  • Manchester, United Kingdom
    • Pfizer Investigational Site
  • Paisley, United Kingdom
    • Pfizer Investigational Site
  • Sheffield, United Kingdom, S10 2JF
    • Pfizer Investigational Site
  • Grampian
    • Aberdeen, Grampian, United Kingdom, AB25 2ZD
      • Pfizer Investigational Site
  • Notts.
    • Nottingham, Notts., United Kingdom, NG7 2UH
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PhXA41	Drug: PhXA41; One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
Active Comparator: timolol	Drug: timolol; One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
to demonstrate the IOP-reducing effect of PhXA41 is comparable to that of timolol at the end of 6 months of treatment	6 mos

Secondary Outcome Measures

Outcome Measure	Time Frame
to describe the IOP development throughout the study period and to follow the safety variables in the two treatment groups.	6 mos

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: December 1, 1992
• Primary Completion (Actual): December 1, 1993
• Study Completion (Actual): December 1, 1993

Study Registration Dates

• First Submitted: September 10, 2008
• First Submitted That Met QC Criteria: September 10, 2008
• First Posted (Estimate): September 11, 2008

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: open angle glaucoma ocular hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Latanoprost
• Other Study ID Numbers: 9200PG005; A6111129