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NCT00801437 Clinical Trial

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

Glaucoma, Open-angle Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00801437
Other study ID # A6641053
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2008
Est. completion date June 2009

Study information
Verified date June 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 457
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - primary open angle glaucoma - ocular hypertension - age >18 years Exclusion Criteria: - bradycardia - obstructive pulmonary disease - hypersensitivity to the drug

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Xalacom
Xalacom 1 drop into the affected eye daily

Locations
Country Name City State
Slovakia Pfizer Investigational Site Banovce N. Bebravou
Slovakia Pfizer Investigational Site Banska Bystrica
Slovakia Pfizer Investigational Site Bojnice
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Brezno
Slovakia Pfizer Investigational Site Dunajska Streda
Slovakia Pfizer Investigational Site Galanta
Slovakia Pfizer Investigational Site Kezmarok
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Krompachy
Slovakia Pfizer Investigational Site Lipany
Slovakia Pfizer Investigational Site Lucenec
Slovakia Pfizer Investigational Site Martin
Slovakia Pfizer Investigational Site Myjava
Slovakia Pfizer Investigational Site Nitra
Slovakia Pfizer Investigational Site Nova Bana
Slovakia Pfizer Investigational Site Nove Mesto N. Vahom
Slovakia Pfizer Investigational Site Nove Zamky
Slovakia Pfizer Investigational Site Poprad
Slovakia Pfizer Investigational Site Presov
Slovakia Pfizer Investigational Site Rimavska Sobota
Slovakia Pfizer Investigational Site Roznava
Slovakia Pfizer Investigational Site Ruzomberok
Slovakia Pfizer Investigational Site Sabinov
Slovakia Pfizer Investigational Site Sala
Slovakia Pfizer Investigational Site Sliac
Slovakia Pfizer Investigational Site Snina
Slovakia Pfizer Investigational Site Spisska Nova Ves
Slovakia Pfizer Investigational Site Stara Lubovna
Slovakia Pfizer Investigational Site Stara Tura
Slovakia Pfizer Investigational Site Topolcany
Slovakia Pfizer Investigational Site Ziar nad Hronom
Slovakia Pfizer Investigational Site Zilina
Slovakia Pfizer Investigational Site Zlate Moravce
Slovakia Pfizer Investigational Site Zvolen

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ocular hyperemia 12 months
Primary safety of treatment 12 months
Secondary effectiveness in IOP lowering 12 months
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