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

NCT00801437

Last updated date
Study Location
Pfizer Investigational Site
Banovce n. Bebravou, , 957 01, Slovakia
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Open-angle Glaucoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- primary open angle glaucoma

- ocular hypertension

- age >18 years

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- bradycardia


- obstructive pulmonary disease


- hypersensitivity to the drug

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Open-angle GlaucomaNon Interventional Study With Primary Open Angle Glaucoma and/or Ocular Hypertension Patients Treated With Xalacom® After Failure of Previous Antiglaucoma Therapy. NCT00801437
  1. Banovce n. Bebravou,
  2. Banska Bystrica,
  3. Bojnice,
  4. Bratislava,
  5. Bratislava,
  6. Bratislava,
  7. Bratislava,
  8. Brezno,
  9. Dunajska Streda,
  10. Galanta,
  11. Kezmarok,
  12. Kosice,
  13. Kosice,
  14. Krompachy,
  15. Lipany,
  16. Lucenec,
  17. Martin,
  18. Myjava,
  19. Nitra,
  20. Nova Bana,
  21. Nove Mesto n. Vahom,
  22. Nove Zamky,
  23. Poprad,
  24. Presov,
  25. Rimavska Sobota,
  26. Roznava,
  27. Ruzomberok,
  28. Sabinov,
  29. Sala,
  30. Sliac,
  31. Snina,
  32. Spisska Nova Ves,
  33. Stara Lubovna,
  34. Stara Tura,
  35. Topolcany,
  36. Ziar nad Hronom,
  37. Zilina,
  38. Zlate Moravce,
  39. Zvolen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title 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.
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients >18 years with primary open angle glaucoma or ocular hypertension
Condition Glaucoma, Open-angle
Intervention Drug: Xalacom
Xalacom 1 drop into the affected eye daily
Study Groups/Cohorts Xalacom treatment
patients with primary glaucoma
Intervention: Drug: Xalacom
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2011)
457
Original Estimated Enrollment
 (submitted: December 2, 2008)
500
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • bradycardia
  • obstructive pulmonary disease
  • hypersensitivity to the drug
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00801437
Other Study ID Numbers A6641053
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2011