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Adherence Improvement in Glaucoma Patients

Primary Purpose

Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Use of TravAlert dosing aid with or without drop guider
Sponsored by
Maastricht University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Glaucoma focused on measuring Glaucoma, Adherence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medisch centrum Alkmaar
  • Wilhelmina ziekenhuis
  • Amphia ziekenhuis
  • Jeroen Bosch ziekenhuis
  • Deventer ziekenhuis
  • Catharina ziekenhuis
  • Groene hart ziekenhuis
  • ziekenhuis de Tjongerschans
  • Atrium medisch centrum
  • Westfries gasthuis
  • University hospital
  • Canisius Wilhelmina ziekenhuis
  • Erasmus medisch centrum
  • Isala klinieken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Outcomes

Primary Outcome Measures

Intraocular pressure

Secondary Outcome Measures

Information with regard to the use of eye drops from data generated by the TravAlert dosing system

Full Information

First Posted
January 15, 2008
Last Updated
February 23, 2010
Sponsor
Maastricht University Medical Center
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00603005
Brief Title
Adherence Improvement in Glaucoma Patients
Official Title
Adherence Improvement in Glaucoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Maastricht University Medical Center
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Adherence

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
802 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Use of TravAlert dosing aid with or without drop guider
Intervention Description
Each patient will use a dosing aid and/or drop guider for 6 months
Primary Outcome Measure Information:
Title
Intraocular pressure
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Information with regard to the use of eye drops from data generated by the TravAlert dosing system
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena J Beckers, MD/phD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medisch centrum Alkmaar
City
Alkmaar
Country
Netherlands
Facility Name
Wilhelmina ziekenhuis
City
Assen
Country
Netherlands
Facility Name
Amphia ziekenhuis
City
Breda
Country
Netherlands
Facility Name
Jeroen Bosch ziekenhuis
City
den Bosch
Country
Netherlands
Facility Name
Deventer ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Catharina ziekenhuis
City
Eindhoven
Country
Netherlands
Facility Name
Groene hart ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
ziekenhuis de Tjongerschans
City
Heerenveen
Country
Netherlands
Facility Name
Atrium medisch centrum
City
Heerlen
Country
Netherlands
Facility Name
Westfries gasthuis
City
Hoorn
Country
Netherlands
Facility Name
University hospital
City
Maastricht
Country
Netherlands
Facility Name
Canisius Wilhelmina ziekenhuis
City
Nijmegen
Country
Netherlands
Facility Name
Erasmus medisch centrum
City
Rotterdam
Country
Netherlands
Facility Name
Isala klinieken
City
Zwolle
Country
Netherlands

12. IPD Sharing Statement

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Adherence Improvement in Glaucoma Patients

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