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

November 4, 2008 updated by: Pfizer
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

976

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2000
        • Pfizer Investigational Site
      • Sydney, New South Wales, Australia, 2067
        • Pfizer Investigational Site
  • Belgium
      • Antwerpen, Belgium, 2020
        • Pfizer Investigational Site
      • Brussel, Belgium, 1090
        • Pfizer Investigational Site
      • Edegem, Belgium, 2650
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, B-4000
        • Pfizer Investigational Site
  • Denmark
      • Kobenhavn O, Denmark, 2100
        • Pfizer Investigational Site
      • Odense C, Denmark, 5000
        • Pfizer Investigational Site
  • France
      • Aire Sur Adour, France, 40800
        • Pfizer Investigational Site
      • Carcassonne, France, 11000
        • Pfizer Investigational Site
      • Dijon, France, 21000
        • Pfizer Investigational Site
      • Figeac, France, 46100
        • Pfizer Investigational Site
      • Haguenau, France, 67500
        • Pfizer Investigational Site
      • Le Cannet, France, 06110
        • Pfizer Investigational Site
      • Loos, France, 59120
        • Pfizer Investigational Site
      • Marseille, France, 13012
        • Pfizer Investigational Site
      • Paris, France, 75011
        • Pfizer Investigational Site
      • Versailles, France, 78000
        • Pfizer Investigational Site
  • Germany
      • Erlangen, Germany, 91052
        • Pfizer Investigational Site
      • Freising, Germany, 85354
        • Pfizer Investigational Site
      • Gerolzhofen, Germany, 97447
        • Pfizer Investigational Site
      • Hirschaid, Germany, 96114
        • Pfizer Investigational Site
      • Hoesbach, Germany, 63768
        • Pfizer Investigational Site
      • Mainz, Germany, 55116
        • Pfizer Investigational Site
      • Mainz, Germany, 55124
        • Pfizer Investigational Site
      • Wuerzburg, Germany, 97070
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 10 672
        • Pfizer Investigational Site
      • Kavala, Greece
        • Pfizer Investigational Site
      • Patras, Greece
        • Pfizer Investigational Site
      • Thessaloniki, Greece
        • Pfizer Investigational Site
    • Nikea-Piraeus
      • Piraeus, Nikea-Piraeus, Greece, 184 54
        • Pfizer Investigational Site
  • Ireland
      • Galway, Ireland
        • Pfizer Investigational Site
    • Co. Clare
      • Ennis, Co. Clare, Ireland
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Firenze, Italy, 50139
        • Pfizer Investigational Site
      • Milano, Italy, 20142
        • Pfizer Investigational Site
      • Padova, Italy, 35100
        • Pfizer Investigational Site
      • Perugia, Italy, 06122
        • Pfizer Investigational Site
      • Pisa, Italy, 56127
        • Pfizer Investigational Site
      • Siena, Italy, 23100
        • Pfizer Investigational Site
      • Torino, Italy
        • Pfizer Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Pfizer Investigational Site
      • Gouda, Netherlands, 2805 AH
        • Pfizer Investigational Site
      • Rijswijk, Netherlands, 2289 CA
        • Pfizer Investigational Site
  • Spain
      • Almeria, Spain, 04009
        • Pfizer Investigational Site
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Lugo, Spain, 27004
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Malaga, Spain, 29009
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
      • Valladolid, Spain, 47005
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50009
        • Pfizer Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Pfizer Investigational Site
      • Terrassa, Barcelona, Spain, 08221
        • Pfizer Investigational Site
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07500
        • Pfizer Investigational Site
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Pfizer Investigational Site
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
  • Sweden
      • Motala, Sweden
        • Pfizer Investigational Site
      • Orebro, Sweden, 701 85
        • Pfizer Investigational Site
      • Stockholm, Sweden
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
      • Vasteras, Sweden, 721 89
        • Pfizer Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G4 0SF
        • Pfizer Investigational Site
      • Lancaster, United Kingdom, LA1 4RP
        • Pfizer Investigational Site
      • London, United Kingdom
        • Pfizer Investigational Site
    • Gloucestershire
      • Bristol, Gloucestershire, United Kingdom, BS1 2LX
        • Pfizer Investigational Site
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Pfizer Investigational Site
    • Lancs
      • Bolton, Lancs, United Kingdom
        • Pfizer Investigational Site
    • Middlesex
      • Uxbridge, Middlesex, United Kingdom, UB8 3NN
        • Pfizer Investigational Site
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UZ
        • Pfizer Investigational Site
    • Surrey
      • Redhill, Surrey, United Kingdom, RH1 5RH
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of increase of iris pigmentation
incidence of development in darkening/lengthening/thickening of eyelashes and/or pigmentation of periorbital skin
occurrence of ocular/periorbital adverse events
occurrence of serious adverse events.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

November 5, 2008

Last Update Submitted That Met QC Criteria

November 4, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 912-OPT-0076-019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ocular Hypertension

Clinical Trials on Xalacom

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe