Non-Interventional Study In Patients With Ocular Hypertension And Open Angle Glaucoma Treated With Xalatan And Xalacom

Verified by: Pfizer, February 2010
First Received: November 11, 2009 | Last Updated: February 18, 2010 | Phase: Phase 4 | Start Date: January 2000
Overall Status: Completed | Estimated Enrollment: 28812
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Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form...

Brief Summary

Official Title: “Project "XCHANGE" Non-Interventional Study”

Non-interventional study to obtain real life data from the treatment with Xalatan and Xalacom in Germany and to assess the long-term efficacy and tolerability under routine conditions. Data were entered into an electronic case report form.

  • Study Type: Observational
  • Study Design: Observational Model: Cohort, Time Perspective: Prospective
  • Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

  • Other: no intervention

Arms, Groups and Cohorts in this Clinical Trial

  • : patients with glaucoma and ocular hypertension

Outcome Measures for this Clinical Trial

Primary Measures

  • Change From Baseline in Intraocular Pressure (IOP)
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Aulhorn Stage (Visual Field Defects)
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No

Secondary Measures

  • Investigator Assessment of Xalatan® Efficacy
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Subject Assessment of Satisfaction With Xalatan® Treatment
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Visual Acuity (Visus)
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Visual Impairment Due to Glaucoma
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Subject Self-care: Application of Eye Drops
    • Time Frame: Baseline, 1 year, 2 years, and 3 years
      Safety Issue?: No
  • Reasons for Changes in Glaucoma Therapy
    • Time Frame: January 2000 through December 2008
      Safety Issue?: Yes
  • Investigator Assessment of Tolerability of Xalatan® Treatment
    • Time Frame: Baseline up to 3 years
      Safety Issue?: Yes
  • Reasons for Discontinuation From Study
    • Time Frame: January 2000 through December 2008
      Safety Issue?: No
  • Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment
    • Time Frame: Baseline up to 3 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • patients with ocular hypertension or glaucoma, defined by SmPC

Exclusion Criteria:

  • defined by SmPC

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01012245

Study ID Number: 912-OPT-0091-131

ClinicalTrials.gov Identifier: NCT01012245

Health Authority: Germany: The German Institute for Drugs and Medical Devices (BfArM) and the Association of Statutory Health Insurance Accredited Physicians (KBV)

To obtain contact information for a study center near you, click here.

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