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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00801437
First received: November 19, 2008
Last updated: June 28, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Glaucoma, Open-angle
Drug: Xalacom
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of ocular hyperemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • safety of treatment [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • effectiveness in IOP lowering [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 457
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Xalacom treatment
patients with primary glaucoma
Drug: Xalacom
Xalacom 1 drop into the affected eye daily

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • bradycardia
  • obstructive pulmonary disease
  • hypersensitivity to the drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00801437

Locations
Slovakia
Pfizer Investigational Site
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, 851 04
Pfizer Investigational Site
Bratislava, Slovakia, 811 05
Pfizer Investigational Site
Bratislava, Slovakia, 833 01
Pfizer Investigational Site
Bratislava, Slovakia, 820 07
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00801437     History of Changes
Other Study ID Numbers: A6641053
Study First Received: November 19, 2008
Last Updated: June 28, 2011
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by Pfizer:
glaucoma, open-angle, non-interventional study, safety, tolerability

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014