Text Size

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

This study is currently recruiting participants.
Verified March 2012 by Meir Medical Center
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
History of Changes
  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:

Drug Information available for: Latanoprost
U.S. FDA Resources

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
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
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
 Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013