Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Non Interventional Study in Slovak Patients With Primary Open Angle Glaucoma and/or Ocular Hypertension Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy Due to Ineffectivity or Intolerance.

This study is designed to evaluate the safety and tolerability of Xalacom in patients with primary glaucoma

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

according to physicians decision, patients who met inclusion and exclusion criteria and sign the ICD

Study Type

Observational

Enrollment (Actual)

457

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

  • Slovakia
      • Banovce N. Bebravou, Slovakia, 957 01
        • Pfizer Investigational Site
      • Banska Bystrica, Slovakia, 975 17
        • Pfizer Investigational Site
      • Bojnice, Slovakia, 972 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 820 07
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 811 05
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 04
        • Pfizer Investigational Site
      • Brezno, Slovakia, 977 01
        • Pfizer Investigational Site
      • Dunajska Streda, Slovakia
        • Pfizer Investigational Site
      • Galanta, Slovakia
        • Pfizer Investigational Site
      • Kezmarok, Slovakia, 060 01
        • Pfizer Investigational Site
      • Kosice, Slovakia, 040 01
        • Pfizer Investigational Site
      • Kosice, Slovakia, 04004
        • Pfizer Investigational Site
      • Krompachy, Slovakia, 053 42
        • Pfizer Investigational Site
      • Lipany, Slovakia, 080 01
        • Pfizer Investigational Site
      • Lucenec, Slovakia, 984 01
        • Pfizer Investigational Site
      • Martin, Slovakia, 036 01
        • Pfizer Investigational Site
      • Myjava, Slovakia, 907 13
        • Pfizer Investigational Site
      • Nitra, Slovakia
        • Pfizer Investigational Site
      • Nova Bana, Slovakia, 968 01
        • Pfizer Investigational Site
      • Nove Mesto N. Vahom, Slovakia, 915 01
        • Pfizer Investigational Site
      • Nove Zamky, Slovakia
        • Pfizer Investigational Site
      • Poprad, Slovakia, 058 01
        • Pfizer Investigational Site
      • Presov, Slovakia, 080 01
        • Pfizer Investigational Site
      • Rimavska Sobota, Slovakia, 979 01
        • Pfizer Investigational Site
      • Roznava, Slovakia, 048 01
        • Pfizer Investigational Site
      • Ruzomberok, Slovakia, 034 01
        • Pfizer Investigational Site
      • Sabinov, Slovakia, 083 01
        • Pfizer Investigational Site
      • Sala, Slovakia
        • Pfizer Investigational Site
      • Sliac, Slovakia, 962 31
        • Pfizer Investigational Site
      • Snina, Slovakia, 06901
        • Pfizer Investigational Site
      • Spisska Nova Ves, Slovakia, 052 01
        • Pfizer Investigational Site
      • Stara Lubovna, Slovakia, 064 01
        • Pfizer Investigational Site
      • Stara Tura, Slovakia, 916 01
        • Pfizer Investigational Site
      • Topolcany, Slovakia, 955 01
        • Pfizer Investigational Site
      • Ziar nad Hronom, Slovakia, 965 01
        • Pfizer Investigational Site
      • Zilina, Slovakia, 010 01
        • Pfizer Investigational Site
      • Zlate Moravce, Slovakia
        • Pfizer Investigational Site
      • Zvolen, Slovakia, 960 01
        • 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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients >18 years with primary open angle glaucoma or ocular hypertension

Description

Inclusion Criteria:

  • primary open angle glaucoma
  • ocular hypertension
  • age >18 years

Exclusion Criteria:

  • bradycardia
  • obstructive pulmonary disease
  • hypersensitivity to the drug

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Xalacom treatment
patients with primary glaucoma
Drug: Xalacom
Xalacom 1 drop into the affected eye daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of ocular hyperemia
Time Frame: 12 months
12 months
safety of treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
effectiveness in IOP lowering
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

October 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

December 2, 2008

First Posted (Estimate)

December 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6641053

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.

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