Effects of Xal-Ease on Patient Compliance With Xalatan

Verified by: Georgia Health Sciences University, August 2008
First Received: December 7, 2007 | Last Updated: August 7, 2008 | Phase: N/A | Start Date: February 2005
Overall Status: Recruiting | Estimated Enrollment: 50
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The study hypothesis is that the Xal-Ease with increase patient compliance with...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Device: Xal-Ease device to be used with Xalatan eye drops
    • This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.

Outcome Measures for this Clinical Trial

Primary Measures

  • 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
      Safety Issue?: No

Secondary Measures

  • To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen
    • Time Frame: six months
      Safety Issue?: No
  • 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
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Georgia Health Sciences University Other

Overall Clinical Trial Officials and Contacts

Christian D. Nilson, MD Principal Investigator Georgia Health Sciences University  

Overall Contact: Christian D. Nilson, MD 706-721-1150 cnilson@mail.mcg.edu

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573638

Study ID Number: 05-02-266

ClinicalTrials.gov Identifier: NCT00573638

Health Authority: United States: Institutional Review Board

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00573638