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Effects of Xal-Ease on Patient Compliance With Xalatan

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Georgia Regents University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Georgia Regents University
ClinicalTrials.gov Identifier:
NCT00573638
First received: December 7, 2007
Last updated: August 7, 2008
Last verified: August 2008
History of Changes
  Purpose

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


Condition Intervention
Glaucoma
 Device: Xal-Ease device to be used with Xalatan eye drops

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen [ Time Frame: six months ] [ Designated as 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2005
Estimated Study Completion Date: December 2009
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.
  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573638

Contacts
Contact: Christian D. Nilson, MD 706-721-1150 cnilson@mail.mcg.edu
Contact: Sandra M. Johnson, MD 706-721-1150 sajohnson@mail.mcg.edu

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

No publications provided

Responsible Party: Michelle Christiano, Medical College of Georgia
ClinicalTrials.gov Identifier: NCT00573638     History of Changes
Other Study ID Numbers: 05-02-266, Guarantor or CPI # 002533552
Study First Received: December 7, 2007
Last Updated: August 7, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Georgia Regents University:
glaucoma
compliance
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:
Glaucoma
Ocular Hypertension
Eye Diseases
Tetrahydrozoline
Latanoprost
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
 Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antihypertensive Agents

ClinicalTrials.gov processed this record on May 21, 2013