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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
  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 ]
  • Aulhorn Stage (Visual Field Defects) [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Change From Baseline in Optic Disc Excavation: Vertical Cup to Disc Ratio [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Change From Baseline in Optic Disc Excavation: Horizontal Cup to Disc Ratio [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]

Secondary Outcome Measures:
  • Investigator Assessment of Xalatan® Efficacy [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Subject Assessment of Satisfaction With Xalatan® Treatment [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Visual Acuity (Visus) [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Visual Impairment Due to Glaucoma [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Subject Self-care: Application of Eye Drops [ Time Frame: Baseline, 1 year, 2 years, and 3 years ]
  • Reasons for Changes in Glaucoma Therapy [ Time Frame: January 2000 through December 2008 ]
  • Investigator Assessment of Tolerability of Xalatan® Treatment [ Time Frame: Baseline up to 3 years ]
  • Reasons for Discontinuation From Study [ Time Frame: January 2000 through December 2008 ]
  • Changes to the Color of the Iris During Xalatan® or Xalacom® Treatment [ Time Frame: Baseline up to 3 years ]

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

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:
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

Keywords provided by Pfizer:
Xchange
Xalatan
Xalacom
Betablocker
observational
longterm

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Antihypertensive Agents

ClinicalTrials.gov processed this record on June 28, 2017