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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01012245
First received: November 11, 2009
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Glaucoma
Ocular Hypertension
Other: no intervention
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Project "XCHANGE" Non-Interventional Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 1 year, 2 years, and 3 years ] [ Designated as safety issue: No ]
  • Aulhorn Stage (Visual Field Defects) [ Time Frame: Baseline, 1 year, 2 years, and 3 years ] [ Designated as 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 ] [ Designated as 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 ] [ Designated as safety issue: No ]

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

Enrollment: 28812
Study Start Date: January 2000
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients with glaucoma and ocular hypertension Other: no intervention
Other Name: no intervention

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with glaucoma or ocular hypertension treated by office-based ophthalmologists

Criteria

Inclusion Criteria:

  • patients with ocular hypertension or glaucoma, defined by SmPC

Exclusion Criteria:

  • defined by SmPC
  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: NCT01012245

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: NCT01012245     History of Changes
Other Study ID Numbers: 912-OPT-0091-131, A6111100, 912-OPT-0091-131
Study First Received: November 11, 2009
Results First Received: December 11, 2009
Last Updated: February 18, 2010
Health Authority: Germany: The German Institute for Drugs and Medical Devices (BfArM) and the Association of Statutory Health Insurance Accredited Physicians (KBV)

Keywords provided by Pfizer:
Xchange
Xalatan
Xalacom
Betablocker
observational
longterm

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

ClinicalTrials.gov processed this record on August 19, 2014