A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within the United Kingdom
NCT ID: NCT00751049
Last Updated: 2021-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
294 participants
INTERVENTIONAL
1992-12-31
1993-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PhXA41
PhXA41
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
timolol
timolol
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
Interventions
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timolol
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle
PhXA41
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Aberdeen, Grampian, United Kingdom
Pfizer Investigational Site
Nottingham, Notts., United Kingdom
Pfizer Investigational Site
Bristol, , United Kingdom
Pfizer Investigational Site
Cambridge, , United Kingdom
Pfizer Investigational Site
Cardiff, , United Kingdom
Pfizer Investigational Site
Dundee, , United Kingdom
Pfizer Investigational Site
Liverpool, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
London, , United Kingdom
Pfizer Investigational Site
Manchester, , United Kingdom
Pfizer Investigational Site
Paisley, , United Kingdom
Pfizer Investigational Site
Sheffield, , United Kingdom
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6111129
Identifier Type: -
Identifier Source: secondary_id
9200PG005
Identifier Type: -
Identifier Source: org_study_id
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