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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
History of Changes
  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:

U.S. FDA Resources

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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 May 16, 2013