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Efficiency of XAL-EASE Device in Glaucoma and/or Ocular Hypertension (OHT) Patients, Treated With Xalatan or Xalacom

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Meir Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01125306
First received: May 16, 2010
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

Xal-Ease is a novel Pfizer-Pharmacia device aimed to significantly facilitate the Xalatan/Xalacom instillation and to avoid loss of Xalatan/Xalacom eye drops due to incorrect instillation.

Patients on Xalatan/Xalacom who have consumed more than one bottle per month within a year according to consumption data drawn from the Clalit Health Services database, will use the Xal-Ease device for a year. The device is expected to reduce consumption of bottles and result in saving money for both patients and medical care providers.


Condition Intervention Phase
Glaucoma
Hypertension
Device: Xal-Ease
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Consumption of Xalatan/Xalacom bottles per year per patient. [ Time Frame: 12 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Characterizing the optimal conditions for proper usage of the Xal-Ease device [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: June 2009
Estimated Study Completion Date: October 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Xal-Ease
    Xal-Ease device used to facilitate application of Xalatan/Xalacom eye drops.
    Other Name: Xal-Ease as a Pfizer-Pharmacia device.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with glaucoma or hypertension treated with Xalatan/Xalacom who have consumed more than one bottle per month within a year prior to initiation of the study.

Exclusion Criteria:

  • Patients younger than 18 years,
  • Patients with severe manual disabilities,
  • Patients with impaired cognition and mentality.
  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: NCT01125306

Locations
Israel
Ophthalmology department, Meir Medical Center Recruiting
Kfar-Saba, Israel, 44281
Contact: Ronit Nesher, MD    972-9747555 ext 2774    nesher.ronit@clalit.org.il   
Principal Investigator: Ronit Nesher, MD         
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:
Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01125306     History of Changes
Other Study ID Numbers: GLAUCOMA/XAL EASE 1
Study First Received: May 16, 2010
Last Updated: March 15, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
Drug consumption
The Xal-Ease device
Patient's compliance
Using a novel Pfizer-Pharmacia device to facilitate the Xalatan/Xalacom instillation and to avoid loss of eye drops

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

ClinicalTrials.gov processed this record on November 27, 2014