Research with human participants

Overview of medical research in the Netherlands

A tilt-detector for the Xal-Ease eye drops delivery aid.
Usability and patient satisfaction.

Published:
Last updated:

Part 1: To determine the effectiveness of self-instillation of fluorescein drops by means of the combined E-Box/Xal-Ease device. Part 2: To determine patient satisfaction of the two administration procedures, i.e. Xal-Ease versus E-Box/Xal-Ease.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Glaucoma and ocular hypertension
Study type
Observational non invasive

ID

NL-OMON32758

Source

ToetsingOnline

Brief title

E-Box & Xal-Ease

Condition

  • Glaucoma and ocular hypertension

Synonym

glaucoma/ocular hypertension

Research involving

Human

Sponsors and support

Primary sponsor :
Oogziekenhuis Rotterdam
Source(s) of monetary or material Support :
Pfizer,Stichting Wetenschappelijk Onderzoek Oogziekenhuis (SWOO)

Intervention

Keyword :
Delivery aid for eye drops, Glaucoma/Ocular hypertension, Patient satisfaction

Outcome measures

Primary outcome

Part 1: Ratio of correctly administered fluorescein drops.

Part 2: Treatment satisfaction score.

Secondary outcome

IOP

Background summary

Glaucoma is a chronic and progressive disease requiring long-term treatment.
Self-instillation of eye drops poses a risk of limited compliance, especially
in the elderly, which affects both health outcome and costs of glaucoma care.
Failure of proper instillation of eye drops can be caused by the incorrect
(vertical) positioning of the bottle relative to the eye. The delivery aid for
Xalatan® (i.e. the Xal-Ease) has been adapted with an auxiliary tool, the
E-Box, comprising a tilt-sensor. The E-Box measures the angle relative to
gravity and provides both an auditory and a visual signal to press the bottle
when positioned correctly.

Study objective

Part 1: To determine the effectiveness of self-instillation of fluorescein
drops by means of the combined E-Box/Xal-Ease device.
Part 2: To determine patient satisfaction of the two administration procedures,
i.e. Xal-Ease versus E-Box/Xal-Ease.

Study design

Part 1: Diagnostic.
Part 2: Open-label, cross-over pilot study.

Study burden and risks

The E-Box does not pose any risk. Possibly, compliance will be improved during
use of the E-Box. Participation requires three extra, study-related, visits to
the Rotterdam Eye Hospital, with each visit taking about 20 minutes.

Public
Oogziekenhuis Rotterdam

Schiedamse Vest 180
3011 BH Rotterdam
NL
Scientific
Oogziekenhuis Rotterdam

Schiedamse Vest 180
3011 BH Rotterdam
NL

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

- Informed consent.
- Age > 18 years.
- Glaucoma or ocular hypertension.
- Use of Xalatan for IOP reduction.

Exclusion criteria

- IOP reducing surgery.
- Auditory impairment.

Design

Study type :
Observational non invasive
Intervention model
:
Crossover
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
20
Type :
Anticipated

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Erasmus MC, Universitair Medisch Centrum Rotterdam (Rotterdam)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL30864.078.09