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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xal-Ease device to be used with Xalatan eye drops
Sponsored by
Augusta University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring 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.

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical College of Georgia Health IncRecruiting

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 7, 2007
Last Updated
August 7, 2008
Sponsor
Augusta University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00573638
Brief Title
Effects of Xal-Ease on Patient Compliance With Xalatan
Acronym
Xal-Ease
Official Title
The Effects of the Xal-Ease Delivery Aid Device on Patient Compliance With Xalatan Eye Drops
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Augusta University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
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.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Xal-Ease device to be used with Xalatan eye drops
Intervention Description
This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen
Time Frame
six months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian D. Nilson, MD
Phone
706-721-1150
Email
cnilson@mail.mcg.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra M. Johnson, MD
Phone
706-721-1150
Email
sajohnson@mail.mcg.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian D. Nilson, MD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical College of Georgia Health Inc
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Effects of Xal-Ease on Patient Compliance With Xalatan

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