A Study of Glaucoma or Ocular Hypertension in Patients Within the United States

NCT ID: NCT00800267

Last Updated: 2021-02-18

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

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-07-31

Study Completion Date

1999-06-30

Brief Summary

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Safety and efficacy study comparing between fixed combination latanoprost-timolol and its component parts.

Detailed Description

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Conditions

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Ocular Hypertension 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

fixed combination latanoprost-timolol

Intervention Type DRUG

one drop in the morning and placebo in the evening

latanoprost 0.005%

Group Type ACTIVE_COMPARATOR

latanoprost 0.005%

Intervention Type DRUG

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

Timolol - 0.5%

Group Type ACTIVE_COMPARATOR

timolol 0.5%

Intervention Type DRUG

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

Intervention Type DRUG

fixed combination latanoprost-timolol

one drop in the morning and placebo in the evening

Intervention Type DRUG

timolol 0.5%

one drop in the morning and evening

Intervention Type DRUG

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 (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

* 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.
* 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.
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

Anaheim, California, United States

Site Status

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Anaheim, California, United States

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Sacramento, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Boulder, Colorado, United States

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Denver, Colorado, United States

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Largo, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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East Point, Georgia, United States

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Griffin, Georgia, United States

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Morrow, Georgia, United States

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Chicago, Illinois, United States

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Wheaton, Illinois, United States

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Elkhart, Indiana, United States

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Mishawaka, Indiana, United States

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South Bend, Indiana, United States

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South Bend, Indiana, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Baltimore, Maryland, United States

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Owings Mills, Maryland, United States

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Boston, Massachusetts, United States

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Golden Valley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Warrensburg, Missouri, United States

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Concord, New Hampshire, United States

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South Plainfield, New Jersey, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Matthews, North Carolina, United States

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Monroe, North Carolina, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Wyomissing, Pennsylvania, United States

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Charleston, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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Charlottesville, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Countries

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United States

Related Links

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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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