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OpenTrials
Completed

NCT Number: NCT00751049

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

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

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open Angle Glaucoma

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Aberdeen, Grampian, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Timolol

Drug

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle

PhXA41

Drug

One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.

Primary outcomes

  1. 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 outcomes

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

    Time frame: 6 mos

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Important dates

Study start
1992
Primary completion
1993
Study completion
1993
First posted
Sep 11, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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