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

March 15, 2012 updated by: Meir Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Saba, Israel, 44281
        • Recruiting
        • Ophthalmology department, Meir Medical Center
        • Contact:
        • Principal Investigator:
          • Ronit Nesher, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Consumption of Xalatan/Xalacom bottles per year per patient.
Time Frame: 12 months.
12 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluating cost of Xalatan/Xalacom eye drops use per year with Xal-Ease
Time Frame: 12 months
12 months
Characterizing the optimal conditions for proper usage of the Xal-Ease device
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Anticipated)

October 1, 2012

Study Registration Dates

First Submitted

May 16, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (Estimate)

May 18, 2010

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLAUCOMA/XAL EASE 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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