Adherence Improvement in Glaucoma Patients
2 other identifiers
interventional
802
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2007
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 15, 2008
CompletedFirst Posted
Study publicly available on registry
January 28, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedFebruary 24, 2010
February 1, 2010
2 years
January 15, 2008
February 23, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intraocular pressure
6 months
Secondary Outcomes (1)
Information with regard to the use of eye drops from data generated by the TravAlert dosing system
6 months
Study Arms (4)
1
EXPERIMENTAL2
EXPERIMENTAL3
EXPERIMENTAL4
EXPERIMENTALInterventions
Each patient will use a dosing aid and/or drop guider for 6 months
Eligibility Criteria
You may qualify if:
- Diagnosis glaucoma or ocular hypertension
- Treatment with travoprost or travoprost/timolol
You may not qualify if:
- High risk of side effects expected from travoprost or travoprost/timolol
- Absolute inability to administer eye drops
- Difficulty in reading or speaking Dutch
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Maastricht University Medical Centerlead
- Alcon Researchcollaborator
Study Sites (14)
Jeroen Bosch ziekenhuis
's-Hertogenbosch, Netherlands
Medisch centrum Alkmaar
Alkmaar, Netherlands
Wilhelmina ziekenhuis
Assen, Netherlands
Amphia ziekenhuis
Breda, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helena J Beckers, MD/phD
Maastricht University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 15, 2008
First Posted
January 28, 2008
Study Start
October 1, 2007
Primary Completion
October 1, 2009
Study Completion
January 1, 2010
Last Updated
February 24, 2010
Record last verified: 2010-02