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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573638
Recruitment Status : Unknown
Verified August 2008 by Augusta University.
Recruitment status was:  Recruiting
First Posted : December 14, 2007
Last Update Posted : August 8, 2008
Information provided by:
Augusta University

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

Condition or disease Intervention/treatment Phase
Glaucoma Device: Xal-Ease device to be used with Xalatan eye drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops
Study Start Date : February 2005
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Intervention Details:
  • 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen [ Time Frame: six months ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573638

Contact: Christian D. Nilson, MD 706-721-1150
Contact: Sandra M. Johnson, MD 706-721-1150

United States, Georgia
Medical College of Georgia Health Inc Recruiting
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Principal Investigator: Christian D. Nilson, MD Augusta University

Responsible Party: Michelle Christiano, Medical College of Georgia Identifier: NCT00573638     History of Changes
Other Study ID Numbers: 05-02-266
Guarantor or CPI # 002533552
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: August 8, 2008
Last Verified: August 2008

Keywords provided by Augusta University:
eye drops
deliver aid
Patients could range anywhere from 40 to 80 years old
Patients must have diagnosis requiring treatment with Xalatan.
Patients will be male or female and from any racial/ethnic background.

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Antihypertensive Agents