A 5-Year Postmarketing Safety Study Of Xalcom In Patients With Open Angle Glaucoma Or Ocular Hypertension

NCT ID: NCT00150267

Last Updated: 2008-11-05

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

976 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Brief Summary

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To estimate the frequency of patients with ocular/periorbital adverse events. To identify any possible long-term adverse consequences of increased iris pigmentation and to follow serious adverse events throughout the study period.

Detailed Description

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Conditions

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Glaucoma, Open-Angle 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

* Patients with open angle glaucoma and/or ocular hypertension requiring a reduction of IOP who were insufficiently responsive to topical betablockers

Exclusion Criteria

* Previous and current treatment with any topical ophthalmic drug containing prostaglandins; any condition in which treatment with the betablocking agent, timolol, was contraindicated.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Sydney, New South Wales, Australia

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Sydney, New South Wales, Australia

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Antwerp, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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København Ø, , Denmark

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Odense C, , Denmark

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Aire Sur Adour, , France

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Carcassonne, , France

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Dijon, , France

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Figeac, , France

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Haguenau, , France

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Le Cannet, , France

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Loos, , France

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Marseille, , France

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Paris, , France

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Versailles, , France

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Erlangen, , Germany

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Freising, , Germany

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Gerolzhofen, , Germany

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Hirschaid, , Germany

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Hösbach, , Germany

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Mainz, , Germany

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Mainz, , Germany

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Würzburg, , Germany

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Piraeus, Nikea-Piraeus, Greece

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Athens, , Greece

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Kavala, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Ennis, Co. Clare, Ireland

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Galway, , Ireland

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Siena, Siena, Italy

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Bologna, , Italy

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Florence, , Italy

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Milan, , Italy

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Padua, , Italy

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Perugia, , Italy

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Pisa, , Italy

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Torino, , Italy

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Alkmaar, , Netherlands

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Gouda, , Netherlands

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Rijswijk, , Netherlands

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Almería, Almeria, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Lugo, Lugo, Spain

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Getafe, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Valencia, Valencia, Spain

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Valladolid, Valladolid, Spain

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Bilbao, Vizcaya, Spain

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Zaragoza, Zaragoza, Spain

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Motala, , Sweden

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Örebro, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Västerås, , Sweden

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Bristol, Gloucestershire, United Kingdom

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Cheltenham, Gloucestershire, United Kingdom

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Bolton, Lancs, United Kingdom

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Uxbridge, Middlesex, United Kingdom

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Norwich, Norfolk, United Kingdom

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Redhill, Surrey, United Kingdom

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Birmingham, , United Kingdom

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Glasgow, , United Kingdom

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Lancaster, , United Kingdom

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London, , United Kingdom

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Countries

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Australia Belgium Denmark France Germany Greece Ireland Italy Netherlands Spain Sweden United Kingdom

Related Links

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Other Identifiers

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912-OPT-0076-019

Identifier Type: -

Identifier Source: org_study_id