Adherence Improvement in Glaucoma Patients

This study has been completed.
Sponsor:
Collaborator:
Alcon Laboratories
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00603005
First received: January 15, 2008
Last updated: February 23, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention
Glaucoma
Device: Use of TravAlert dosing aid with or without drop guider

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Supportive Care
Official Title: Adherence Improvement in Glaucoma Patients

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Intraocular pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Information with regard to the use of eye drops from data generated by the TravAlert dosing system [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 802
Study Start Date: October 2007
Study Completion Date: January 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603005

Locations
Netherlands
Medisch centrum Alkmaar
Alkmaar, Netherlands
Wilhelmina ziekenhuis
Assen, Netherlands
Amphia ziekenhuis
Breda, Netherlands
Jeroen Bosch ziekenhuis
den Bosch, Netherlands
Deventer ziekenhuis
Deventer, Netherlands
Catharina ziekenhuis
Eindhoven, Netherlands
Groene hart ziekenhuis
Gouda, Netherlands
ziekenhuis de Tjongerschans
Heerenveen, Netherlands
Atrium medisch centrum
Heerlen, Netherlands
Westfries gasthuis
Hoorn, Netherlands
University hospital
Maastricht, Netherlands
Canisius Wilhelmina ziekenhuis
Nijmegen, Netherlands
Erasmus medisch centrum
Rotterdam, Netherlands
Isala klinieken
Zwolle, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Alcon Laboratories
Investigators
Principal Investigator: Helena J Beckers, MD/phD Maastricht University Medical Center
  More Information

No publications provided

Responsible Party: Dr. H.J.M. Beckers, MD, phD, Department of Ophthalmology, University Hospital Maastricht
ClinicalTrials.gov Identifier: NCT00603005     History of Changes
Other Study ID Numbers: MEC 07-1-015, CTCM-071015
Study First Received: January 15, 2008
Last Updated: February 23, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Glaucoma
Adherence

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014