Adherence Improvement in Glaucoma Patients

NCT ID: NCT00603005

Last Updated: 2010-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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1

Group Type EXPERIMENTAL

Use of TravAlert dosing aid with or without drop guider

Intervention Type DEVICE

Each patient will use a dosing aid and/or drop guider for 6 months

2

Group Type EXPERIMENTAL

Use of TravAlert dosing aid with or without drop guider

Intervention Type DEVICE

Each patient will use a dosing aid and/or drop guider for 6 months

3

Group Type EXPERIMENTAL

Use of TravAlert dosing aid with or without drop guider

Intervention Type DEVICE

Each patient will use a dosing aid and/or drop guider for 6 months

4

Group Type EXPERIMENTAL

Use of TravAlert dosing aid with or without drop guider

Intervention Type DEVICE

Each patient will use a dosing aid and/or drop guider for 6 months

Interventions

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Use of TravAlert dosing aid with or without drop guider

Each patient will use a dosing aid and/or drop guider for 6 months

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology, University Hospital Maastricht

Principal Investigators

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Helena J Beckers, MD/phD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University Medical Center

Locations

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Jeroen Bosch ziekenhuis

's-Hertogenbosch, , Netherlands

Site Status

Medisch centrum Alkmaar

Alkmaar, , Netherlands

Site Status

Wilhelmina ziekenhuis

Assen, , Netherlands

Site Status

Amphia ziekenhuis

Breda, , Netherlands

Site Status

Deventer ziekenhuis

Deventer, , Netherlands

Site Status

Catharina ziekenhuis

Eindhoven, , Netherlands

Site Status

Groene hart ziekenhuis

Gouda, , Netherlands

Site Status

ziekenhuis de Tjongerschans

Heerenveen, , Netherlands

Site Status

Atrium medisch centrum

Heerlen, , Netherlands

Site Status

Westfries gasthuis

Hoorn, , Netherlands

Site Status

University hospital

Maastricht, , Netherlands

Site Status

Canisius Wilhelmina ziekenhuis

Nijmegen, , Netherlands

Site Status

Erasmus medisch centrum

Rotterdam, , Netherlands

Site Status

Isala klinieken

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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CTCM-071015

Identifier Type: -

Identifier Source: secondary_id

MEC 07-1-015

Identifier Type: -

Identifier Source: org_study_id

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