A Study of Open Angle Glaucoma or Ocular Hypertension in Patients Within Scandinavia
NCT ID: NCT00751062
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
267 participants
INTERVENTIONAL
1992-11-30
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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Timolol
timolol
One drop in the affected eye every morning from the morning bottle and one drop every evening from the evening bottle.
PhXA41
PhXA41
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.
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
Hellerup, , Denmark
Pfizer Investigational Site
Vejle, , Denmark
Pfizer Investigational Site
Oulu, , Finland
Pfizer Investigational Site
Bergen, , Norway
Pfizer Investigational Site
Oslo, , Norway
Pfizer Investigational Site
Trondheim, , Norway
Pfizer Investigational Site
Gothenburg, , Sweden
Pfizer Investigational Site
Huddinge, , Sweden
Pfizer Investigational Site
Linköping, , Sweden
Pfizer Investigational Site
Lund, , Sweden
Pfizer Investigational Site
Malmo, , Sweden
Pfizer Investigational Site
Umeå, , Sweden
Pfizer Investigational Site
Uppsala, , Sweden
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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A6111130
Identifier Type: -
Identifier Source: secondary_id
9200PG006
Identifier Type: -
Identifier Source: org_study_id
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