A Study Demonstrating The Effect Of Latanoprost In Combination With Timolol, Latanoprost Alone And Timolol Alone On Eye Pressure In Open Angle Glaucoma Or Ocular Hypertension In Patients
NCT ID: NCT00856622
Last Updated: 2021-02-21
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
436 participants
INTERVENTIONAL
1997-08-31
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%
i. Fixed combination of latanoprost 0.005% and timolol 0.5%
one drop in the morning and placebo in the evening
timolol 0.5% ophthalmic solution
one drop in the morning and evening
timolol 0.5% ophthalmic solution
one drop in the morning and evening
latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening
latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening
Interventions
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i. Fixed combination of latanoprost 0.005% and timolol 0.5%
one drop in the morning and placebo in the evening
timolol 0.5% ophthalmic solution
one drop in the morning and evening
latanoprost 0.005% ophthalmic solution
placebo in the morning and latanoprost .005% in the evening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients currently on IOP reducing therapy: IOP greater than or equal to 25mmHg (two 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.
* Cardiac failure, sinus bradycardia, second and third degree of atrioventricular block. (The routines for prescribing topical B-blocking agents will be followed.
* Bronchial asthma, history of bronchial asthma or chronic obstructive pulmonary disease. (The routines for prescribing topical B-blocking agents will be followed).
* Pregnancy
* Women of childbearing potential who has not used adequate contraceptive methods during the last three months.
* 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
Aachen, , Germany
Pfizer Investigational Site
Aalen, , Germany
Pfizer Investigational Site
Ahaus, , Germany
Pfizer Investigational Site
Alzey, , Germany
Pfizer Investigational Site
Aschaffenburg, , Germany
Pfizer Investigational Site
Bad Abbach, , Germany
Pfizer Investigational Site
Berlin, , Germany
Pfizer Investigational Site
Coesfeld, , Germany
Pfizer Investigational Site
Dillingen, , Germany
Pfizer Investigational Site
Eitorf, , Germany
Pfizer Investigational Site
Erlangen, , Germany
Pfizer Investigational Site
Essen, , Germany
Pfizer Investigational Site
Freiburg im Breisgau, , Germany
Pfizer Investigational Site
Freising, , Germany
Pfizer Investigational Site
Fulda, , Germany
Pfizer Investigational Site
Greifswald, , Germany
Pfizer Investigational Site
Gummersbach, , Germany
Pfizer Investigational Site
Hanover, , Germany
Pfizer Investigational Site
Hirschaid, , Germany
Pfizer Investigational Site
Iserlohn, , Germany
Pfizer Investigational Site
Koblenz, , Germany
Pfizer Investigational Site
Leonberg, , Germany
Pfizer Investigational Site
Leverkusen, , Germany
Pfizer Investigational Site
Mainz, , Germany
Pfizer Investigational Site
Mainz, , Germany
Pfizer Investigational Site
Mainz, , Germany
Pfizer Investigational Site
Mülheim, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
München, , Germany
Pfizer Investigational Site
Münster, , Germany
Pfizer Investigational Site
Offenbach, , Germany
Pfizer Investigational Site
Osnabrück, , Germany
Pfizer Investigational Site
Parsberg, , Germany
Pfizer Investigational Site
Siegburg, , Germany
Pfizer Investigational Site
Sulzbach, , Germany
Pfizer Investigational Site
Trier, , Germany
Pfizer Investigational Site
Weiden, , Germany
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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A6641005
Identifier Type: -
Identifier Source: secondary_id
96TIPG004
Identifier Type: -
Identifier Source: org_study_id
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