A Study of Glaucoma or Ocular Hypertension in Patients Within the United States
NCT ID: NCT00800267
Last Updated: 2021-02-18
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
418 participants
INTERVENTIONAL
1997-07-31
1999-06-30
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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Fixed combination of latanoprost 0.005% and timolol 0.5%
fixed combination latanoprost-timolol
one drop in the morning and placebo in the evening
latanoprost 0.005%
latanoprost 0.005%
placebo in the morning and latanoprost .005% in the evening
Timolol - 0.5%
timolol 0.5%
one drop in the morning and evening
Interventions
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latanoprost 0.005%
placebo in the morning and latanoprost .005% in the evening
fixed combination latanoprost-timolol
one drop in the morning and placebo in the evening
timolol 0.5%
one drop in the morning and evening
Eligibility Criteria
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Inclusion Criteria
* Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (Ltwo IOP determinations at pre-study separated by at least one hour) OR Patients without IOP reducing therapy: IOP greater than or equal to 30mmHg (two IOP determinations at pre-study separated by at least one hour).
Exclusion Criteria
* Current use of contact lenses.
* Ocular surgery or argon laser trabeculoplasty (ALT) within three months prior to pre-study visit.
* Ocular inflammation/infection occurring within three months prior to pre-study visit.
* Hypersensitivity to benzalkonium chloride or to any other component of the study drug solutions.
* Other abnormal ocular condition or symptom preventing the patient from entering the study, according to the investigator's judgement.
* Patients with conditions in which treatment with B-blocking agents are contraindicated: cardiac failure, sinus bradycardia, second and third degree atrio-ventricular block.
* Patients with conditions in which treatment with B-blocking agents are contraindicated: bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease.
* Inability to adhere to treatment/visit plan.
* Have participated in any other clinical study within one month prior to pre-study visit.
18 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
Anaheim, California, United States
Pfizer Investigational Site
Anaheim, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
Sacramento, California, United States
Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Boulder, Colorado, United States
Pfizer Investigational Site
Denver, Colorado, United States
Pfizer Investigational Site
Largo, Florida, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
East Point, Georgia, United States
Pfizer Investigational Site
Griffin, Georgia, United States
Pfizer Investigational Site
Morrow, Georgia, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Wheaton, Illinois, United States
Pfizer Investigational Site
Elkhart, Indiana, United States
Pfizer Investigational Site
Mishawaka, Indiana, United States
Pfizer Investigational Site
South Bend, Indiana, United States
Pfizer Investigational Site
South Bend, Indiana, United States
Pfizer Investigational Site
Iowa City, Iowa, United States
Pfizer Investigational Site
Louisville, Kentucky, United States
Pfizer Investigational Site
Baltimore, Maryland, United States
Pfizer Investigational Site
Owings Mills, Maryland, United States
Pfizer Investigational Site
Boston, Massachusetts, United States
Pfizer Investigational Site
Golden Valley, Minnesota, United States
Pfizer Investigational Site
Minneapolis, Minnesota, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
Warrensburg, Missouri, United States
Pfizer Investigational Site
Concord, New Hampshire, United States
Pfizer Investigational Site
South Plainfield, New Jersey, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Charlotte, North Carolina, United States
Pfizer Investigational Site
Matthews, North Carolina, United States
Pfizer Investigational Site
Monroe, North Carolina, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Portland, Oregon, United States
Pfizer Investigational Site
Wyomissing, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Mt. Pleasant, South Carolina, United States
Pfizer Investigational Site
Memphis, Tennessee, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Galveston, Texas, United States
Pfizer Investigational Site
Houston, Texas, United States
Pfizer Investigational Site
Charlottesville, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Richmond, Virginia, United States
Pfizer Investigational Site
Tacoma, Washington, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Pfizer Investigational Site
Madison, Wisconsin, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A6641006
Identifier Type: -
Identifier Source: secondary_id
96TIPG005
Identifier Type: -
Identifier Source: org_study_id
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