A 6 Month Study Comparing Latanoprost With Timolol in Patients With Open Angle Glaucoma or Ocular Hypertension
NCT ID: NCT00751127
Last Updated: 2011-03-25
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
268 participants
INTERVENTIONAL
1993-01-31
1994-02-28
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
TRIPLE
Study Groups
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Timolol
timolol
One drop in the affected eye twice daily for six months.
PhXA41
PhXA41
One drop in the affected eye once daily for six months.
Interventions
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PhXA41
One drop in the affected eye once daily for six months.
timolol
One drop in the affected eye twice daily for six months.
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
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
La Jolla, California, United States
Pfizer Investigational Site
Los Angeles, California, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Pfizer Investigational Site
St Louis, Missouri, United States
Pfizer Investigational Site
Omaha, Nebraska, United States
Pfizer Investigational Site
River Edge, New Jersey, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
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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9200PG004
Identifier Type: -
Identifier Source: org_study_id
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