Effects of Xal-Ease on Patient Compliance With Xalatan (Xal-Ease)

August 7, 2008 updated by: Augusta University

The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops

The study hypothesis is that the Xal-Ease with increase patient compliance with XALATAN

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

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

  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Medical College of Georgia Health Inc

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 to 80 years old
  • Diagnosis warranting treatment with Xalatan eye drops.
  • ambulatory and well functioning

Exclusion Criteria:

  • non-ambulatory
  • less than 40 or greater than 80 years old
  • Not using Xalatan eye drops

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment.
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen
Time Frame: six months
six months
To see whether or not the Xal-Ease device helps patients conserve medication. ie - aids in drops not distilled in the eye.
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Augusta University

Collaborators

Pfizer

Investigators

  • Principal Investigator: Christian D. Nilson, MD, Augusta University

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

February 1, 2005

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

December 7, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 14, 2007

Study Record Updates

Last Update Posted (Estimate)

August 8, 2008

Last Update Submitted That Met QC Criteria

August 7, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-02-266
  • Guarantor or CPI # 002533552

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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