NCT00573638

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 8, 2008

Status Verified

August 1, 2008

First QC Date

December 7, 2007

Last Update Submit

August 7, 2008

Conditions

Glaucoma

Keywords

glaucomacomplianceeye dropsdeliver aidPatients could range anywhere from 40 to 80 years oldPatients must have diagnosis requiring treatment with Xalatan.Patients will be male or female and from any racial/ethnic background.

Outcome Measures

Primary Outcomes (1)

  • The primary outcome measure is compliance with the medication XALATAN using and not using the Xal-Ease delivery aid for their glaucoma treatment.

    six months

Secondary Outcomes (2)

  • To determine if any of the other factors mentioned in the survey affect compliance to their medical regimen

    six months

  • To see whether or not the Xal-Ease device helps patients conserve medication. ie - aids in drops not distilled in the eye.

    6 months

Interventions

Xal-Ease device to be used with Xalatan eye dropsDEVICE

This intervention is a drop instillation guide to be used in conjunction with the FDA approved Xalatan eye drop.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical College of Georgia Health Inc

Augusta, Georgia, 30912, United States

RECRUITING

MeSH Terms

Conditions

GlaucomaPatient Compliance

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Christian D. Nilson, MD

    Augusta University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian D. Nilson, MD

CONTACT

706-721-1150cnilson@mail.mcg.edu

Sandra M. Johnson, MD

CONTACT

706-721-1150sajohnson@mail.mcg.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 14, 2007

Study Start

February 1, 2005

Study Completion

December 1, 2009

Last Updated

August 8, 2008

Record last verified: 2008-08

Locations

US(1)