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NCT00603005 Clinical Trial

Adherence Improvement in Glaucoma Patients

Glaucoma Clinical Trial

Official title:
Adherence Improvement in Glaucoma Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00603005
Other study ID # MEC 07-1-015
Secondary ID CTCM-071015
Status Completed
Phase N/A
First received January 15, 2008
Last updated February 23, 2010
Start date October 2007
Est. completion date January 2010

Study information
Verified date February 2010
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 802
Est. completion date January 2010
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
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

Sponsors (2)
Lead Sponsor Collaborator
Maastricht University Medical Center Alcon Research

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure 6 months No
Secondary Information with regard to the use of eye drops from data generated by the TravAlert dosing system 6 months No
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