Adherence Improvement in Glaucoma Patients

February 23, 2010 updated by: Maastricht University Medical Center
The purpose of this study is to study the effect on intraocular pressure in glaucoma patients using the TravAlert dosing aid with or without the Eyot drop guider and with or without additional patient education.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

802

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands
        • Medisch Centrum Alkmaar
      • Assen, Netherlands
        • Wilhelmina Ziekenhuis
      • Breda, Netherlands
        • Amphia Ziekenhuis
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Eindhoven, Netherlands
        • Catharina Ziekenhuis
      • Gouda, Netherlands
        • Groene Hart Ziekenhuis
      • Heerenveen, Netherlands
        • Ziekenhuis De Tjongerschans
      • Heerlen, Netherlands
        • Atrium medisch centrum
      • Hoorn, Netherlands
        • Westfries Gasthuis
      • Maastricht, Netherlands
        • University Hospital
      • Nijmegen, Netherlands
        • Canisius Wilhelmina Ziekenhuis
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
      • Zwolle, Netherlands
        • Isala Klinieken
      • den Bosch, Netherlands
        • Jeroen Bosch Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis glaucoma or ocular hypertension
  • Treatment with travoprost or travoprost/timolol

Exclusion Criteria:

  • High risk of side effects expected from travoprost or travoprost/timolol
  • Absolute inability to administer eye drops
  • Difficulty in reading or speaking Dutch

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Device: Use of TravAlert dosing aid with or without drop guider
Each patient will use a dosing aid and/or drop guider for 6 months
Experimental: 2
Device: Use of TravAlert dosing aid with or without drop guider
Each patient will use a dosing aid and/or drop guider for 6 months
Experimental: 3
Device: Use of TravAlert dosing aid with or without drop guider
Each patient will use a dosing aid and/or drop guider for 6 months
Experimental: 4
Device: Use of TravAlert dosing aid with or without drop guider
Each patient will use a dosing aid and/or drop guider for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraocular pressure
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Information with regard to the use of eye drops from data generated by the TravAlert dosing system
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Collaborators

Alcon Research

Investigators

  • Principal Investigator: Helena J Beckers, MD/phD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 26, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 24, 2010

Last Update Submitted That Met QC Criteria

February 23, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEC 07-1-015
  • CTCM-071015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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