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A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

NCT ID: NCT00140049

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

PHASE4

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-07-31

Brief Summary

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To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon \& 4 PM during a 12 week treatment.

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Detailed Description

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Conditions

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Glaucoma, Open Angle Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Xalacom

Intervention Type DRUG

Cosopt

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening

Exclusion Criteria

* Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
* History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
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

Caen, , France

Site Status

Pfizer Investigational Site

Clermont-Ferrand, , France

Site Status

Pfizer Investigational Site

Lyon, , France

Site Status

Pfizer Investigational Site

Marseille, , France

Site Status

Pfizer Investigational Site

Saint-Herblain, , France

Site Status

Pfizer Investigational Site

Darmstadt, , Germany

Site Status

Pfizer Investigational Site

Darmstadt, , Germany

Site Status

Pfizer Investigational Site

Landau / Pfalz, , Germany

Site Status

Pfizer Investigational Site

Regenstauf, , Germany

Site Status

Pfizer Investigational Site

Schorndorf, , Germany

Site Status

Pfizer Investigational Site

Starnberg, , Germany

Site Status

Pfizer Investigational Site

Heraklion, Crete, Greece

Site Status

Pfizer Investigational Site

Thessaloniki, Macedonia, Greece

Site Status

Pfizer Investigational Site

Alexandroupoli, , Greece

Site Status

Pfizer Investigational Site

Larissa, , Greece

Site Status

Pfizer Investigational Site

Chieti, , Italy

Site Status

Pfizer Investigational Site

Foggia, , Italy

Site Status

Pfizer Investigational Site

Genova, , Italy

Site Status

Pfizer Investigational Site

Milan, , Italy

Site Status

Pfizer Investigational Site

Monza (MI), , Italy

Site Status

Pfizer Investigational Site

Pisa, , Italy

Site Status

Pfizer Investigational Site

örebro, , Sweden

Site Status

Pfizer Investigational Site

Malmo, , Sweden

Site Status

Pfizer Investigational Site

Mölndal, , Sweden

Site Status

Pfizer Investigational Site

Sundsvall, , Sweden

Site Status

Countries

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France Germany Greece Italy Sweden

Other Identifiers

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A6641038

Identifier Type: -

Identifier Source: org_study_id

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