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Evaluation Of Intraocular Pressure Lowering-Effect Of Xalacom In Patients With Poag Or Oh.

NCT ID: NCT00143208

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

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-04-30

Brief Summary

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This study is designed as an open label evaluation of the efficacy of latanoprost and timolol fixed combination (Xalacom) after 6 month of treatment. Eligible patients may be enrolled at the baseline visit. All current ocular hypotensive therapy must be discontinued at this time. On baseline day, patients eligible for the study will receive Xalacom which is to be instilled in the morning.

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Detailed Description

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Conditions

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Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Xalacom

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of glaucoma (primary open angle, pigmentary, exfoliative) or ocular hypertension (IOP \>= 21 mmHG).
* Visual acuity \>= 20/200.

Exclusion Criteria

* Closed/barely open anterior chamber angle or history of acute angle closure glaucoma.
* Hystory of ALT within 3 months prior to the baseline visit.
* History of any ocular filtering surgical intervention.
* Ocular surgery or inflammation/infection within 3 months prior to the baseline 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

Arezzo, , Italy

Site Status

Pfizer Investigational Site

Bari, , Italy

Site Status

Pfizer Investigational Site

Bollate, , Italy

Site Status

Pfizer Investigational Site

Bologna, , Italy

Site Status

Pfizer Investigational Site

Caserta, , Italy

Site Status

Pfizer Investigational Site

Catanzaro, , Italy

Site Status

Pfizer Investigational Site

Conegliano, , Italy

Site Status

Pfizer Investigational Site

Desenzano (BS), , Italy

Site Status

Pfizer Investigational Site

Ferrara, , Italy

Site Status

Pfizer Investigational Site

Livorno, , Italy

Site Status

Pfizer Investigational Site

Massafra, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Napoli, , Italy

Site Status

Pfizer Investigational Site

Orbassano, , Italy

Site Status

Pfizer Investigational Site

Palermo, , Italy

Site Status

Pfizer Investigational Site

Pavia, , Italy

Site Status

Pfizer Investigational Site

Pescara, , Italy

Site Status

Pfizer Investigational Site

Ragusa, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Roma, , Italy

Site Status

Pfizer Investigational Site

Sassari, , Italy

Site Status

Countries

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Italy

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=XALACO-0076-033&StudyName=Evaluation+Of+Intraocular+Pressure+Lowering%2DEffect+Of+Xalacom+In+Patients+With+Poag+Or+Oh%2E

To obtain contact information for a study center near you, click here.

Other Identifiers

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XALACO-0076-033

Identifier Type: -

Identifier Source: org_study_id

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