NCT00603005

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
802

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 24, 2010

Status Verified

February 1, 2010

Enrollment Period

2 years

First QC Date

January 15, 2008

Last Update Submit

February 23, 2010

Conditions

Keywords

GlaucomaAdherence

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

EXPERIMENTAL
Device: Use of TravAlert dosing aid with or without drop guider

2

EXPERIMENTAL
Device: Use of TravAlert dosing aid with or without drop guider

3

EXPERIMENTAL
Device: Use of TravAlert dosing aid with or without drop guider

4

EXPERIMENTAL
Device: Use of TravAlert dosing aid with or without drop guider

Interventions

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

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Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (14)

Jeroen Bosch ziekenhuis

's-Hertogenbosch, Netherlands

Location

Medisch centrum Alkmaar

Alkmaar, Netherlands

Location

Wilhelmina ziekenhuis

Assen, Netherlands

Location

Amphia ziekenhuis

Breda, Netherlands

Location

Deventer ziekenhuis

Deventer, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Netherlands

Location

Groene hart ziekenhuis

Gouda, Netherlands

Location

ziekenhuis de Tjongerschans

Heerenveen, Netherlands

Location

Atrium medisch centrum

Heerlen, Netherlands

Location

Westfries gasthuis

Hoorn, Netherlands

Location

University hospital

Maastricht, Netherlands

Location

Canisius Wilhelmina ziekenhuis

Nijmegen, Netherlands

Location

Erasmus medisch centrum

Rotterdam, Netherlands

Location

Isala klinieken

Zwolle, Netherlands

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Helena J Beckers, MD/phD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

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

Locations