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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

436 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-08-31

Study Completion Date

1999-06-30

Brief Summary

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The purpose of this study is to demonstrate that fixed combination of latanoprost and timolol (PhXA41) has better IOP lowering effect than the individual monotherapies.

Detailed Description

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Conditions

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Ocular Hypertension Glaucoma Open-angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fixed combination of latanoprost 0.005% and timolol 0.5%

Group Type EXPERIMENTAL

i. Fixed combination of latanoprost 0.005% and timolol 0.5%

Intervention Type DRUG

one drop in the morning and placebo in the evening

timolol 0.5% ophthalmic solution

one drop in the morning and evening

Group Type ACTIVE_COMPARATOR

timolol 0.5% ophthalmic solution

Intervention Type DRUG

one drop in the morning and evening

latanoprost 0.005% ophthalmic solution

placebo in the morning and latanoprost .005% in the evening

Group Type ACTIVE_COMPARATOR

latanoprost 0.005% ophthalmic solution

Intervention Type DRUG

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

Intervention Type DRUG

timolol 0.5% ophthalmic solution

one drop in the morning and evening

Intervention Type DRUG

latanoprost 0.005% ophthalmic solution

placebo in the morning and latanoprost .005% in the evening

Intervention Type DRUG

Other Intervention Names

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xalacom, xalcom timoptic xalatan

Eligibility Criteria

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Inclusion Criteria

* Unilateral or bilateral primary open angle glaucoma, capsular glaucoma, pigmentary glaucoma or ocular hypertension.
* 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

* History of acute angle closure or closed/barely open anterior chamber angle.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Pfizer Investigational Site

Aalen, , Germany

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Pfizer Investigational Site

Ahaus, , Germany

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Pfizer Investigational Site

Alzey, , Germany

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Pfizer Investigational Site

Aschaffenburg, , Germany

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Pfizer Investigational Site

Bad Abbach, , Germany

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Pfizer Investigational Site

Berlin, , Germany

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Pfizer Investigational Site

Coesfeld, , Germany

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Pfizer Investigational Site

Dillingen, , Germany

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Pfizer Investigational Site

Eitorf, , Germany

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Pfizer Investigational Site

Erlangen, , Germany

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Pfizer Investigational Site

Essen, , Germany

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Pfizer Investigational Site

Freiburg im Breisgau, , Germany

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Pfizer Investigational Site

Freising, , Germany

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Pfizer Investigational Site

Fulda, , Germany

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Pfizer Investigational Site

Greifswald, , Germany

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Pfizer Investigational Site

Gummersbach, , Germany

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Pfizer Investigational Site

Hanover, , Germany

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Pfizer Investigational Site

Hirschaid, , Germany

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Pfizer Investigational Site

Iserlohn, , Germany

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Pfizer Investigational Site

Koblenz, , Germany

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Pfizer Investigational Site

Leonberg, , Germany

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Pfizer Investigational Site

Leverkusen, , Germany

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Pfizer Investigational Site

Mainz, , Germany

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Pfizer Investigational Site

Mainz, , Germany

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Pfizer Investigational Site

Mainz, , Germany

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Pfizer Investigational Site

Mülheim, , Germany

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Pfizer Investigational Site

München, , Germany

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Pfizer Investigational Site

München, , Germany

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Pfizer Investigational Site

Münster, , Germany

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Pfizer Investigational Site

Offenbach, , Germany

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Pfizer Investigational Site

Osnabrück, , Germany

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Pfizer Investigational Site

Parsberg, , Germany

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Pfizer Investigational Site

Siegburg, , Germany

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Pfizer Investigational Site

Sulzbach, , Germany

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Pfizer Investigational Site

Trier, , Germany

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Pfizer Investigational Site

Weiden, , Germany

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Countries

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Germany

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=96TIPG004

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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