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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751049
Recruitment Status : Completed
First Posted : September 11, 2008
Last Update Posted : September 11, 2008
Information provided by:

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

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open Angle Glaucoma Drug: timolol Drug: PhXA41 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 1992
Actual Primary Completion Date : December 1993
Actual Study Completion Date : December 1993

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751049

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United Kingdom
Pfizer Investigational Site
Aberdeen, Grampian, United Kingdom, AB25 2ZD
Pfizer Investigational Site
Nottingham, Notts., United Kingdom, NG7 2UH
Pfizer Investigational Site
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
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00751049    
Other Study ID Numbers: 9200PG005
First Posted: September 11, 2008    Key Record Dates
Last Update Posted: September 11, 2008
Last Verified: September 2008
Keywords provided by Pfizer:
open angle glaucoma ocular hypertension
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents