Clinical trial NCT00801437: Non Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy.
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-angle
Keywords: glaucoma, open-angle, non-interventional study, safety, tolerability
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>18 years with primary open angle glaucoma or ocular hypertension

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

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

Eligibility criteria: Inclusion Criteria:

* primary open angle glaucoma
* ocular hypertension
* age \>18 years

Exclusion Criteria:

* bradycardia
* obstructive pulmonary disease
* hypersensitivity to the drug

Primary outcomes:
measure: Incidence of ocular hyperemia
timeFrame: 12 months
measure: safety of treatment
timeFrame: 12 months
Secondary outcomes:
measure: effectiveness in IOP lowering
timeFrame: 12 months
Other outcomes:
Locations:
city: Banovce N. Bebravou
country: Slovakia
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bojnice
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Brezno
country: Slovakia
facility: Pfizer Investigational Site
city: Dunajska Streda
country: Slovakia
facility: Pfizer Investigational Site
city: Galanta
country: Slovakia
facility: Pfizer Investigational Site
city: Kezmarok
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Krompachy
country: Slovakia
facility: Pfizer Investigational Site
city: Lipany
country: Slovakia
facility: Pfizer Investigational Site
city: Lucenec
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Myjava
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Nova Bana
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Mesto N. Vahom
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Poprad
country: Slovakia
facility: Pfizer Investigational Site
city: Presov
country: Slovakia
facility: Pfizer Investigational Site
city: Rimavska Sobota
country: Slovakia
facility: Pfizer Investigational Site
city: Roznava
country: Slovakia
facility: Pfizer Investigational Site
city: Ruzomberok
country: Slovakia
facility: Pfizer Investigational Site
city: Sabinov
country: Slovakia
facility: Pfizer Investigational Site
city: Sala
country: Slovakia
facility: Pfizer Investigational Site
city: Sliac
country: Slovakia
facility: Pfizer Investigational Site
city: Snina
country: Slovakia
facility: Pfizer Investigational Site
city: Spisska Nova Ves
country: Slovakia
facility: Pfizer Investigational Site
city: Stara Lubovna
country: Slovakia
facility: Pfizer Investigational Site
city: Stara Tura
country: Slovakia
facility: Pfizer Investigational Site
city: Topolcany
country: Slovakia
facility: Pfizer Investigational Site
city: Ziar nad Hronom
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Zlate Moravce
country: Slovakia
facility: Pfizer Investigational Site
city: Zvolen
country: Slovakia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: