To study the effect on intraocular pressure in patients using the Travalert dosing aid with or without the additional use of the Eyot and with of without additional patient education.
ID
Source
Brief title
Condition
- Glaucoma and ocular hypertension
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint is the intraocular pressure measured at the ophthalmologists
office.
Secondary outcome
Secondary endpoints are the registration of adherence by the Travalert, the
weight of the medication bottles, patient satisfaction and refill compliance in
the next three years.
Background summary
Non-adherence with prescribed topical therapy is a frequently encountered
problem in glaucoma patients of which the impact on intraocular pressure levels
and visual field loss is not yet known.
Non-adherence may possibly be improved with the use of electronic monitoring
devices and/or drop aids. The Travalert* dosing aid is a recently developed
monitoring device for the use of travoprost (Travatan*) or the fixed
combination timolol-travoprost (Duotrav*) eye drops. The use of a drop guider
(Travalert*-Eyot*), fastened onto the Travalert, may be of additional value for
the correct instillation of drops into the eye. Patient education may also be
useful to achieve better adherence with medication.
Study objective
To study the effect on intraocular pressure in patients using the Travalert
dosing aid with or without the additional use of the Eyot and with of without
additional patient education.
Study design
randomized clinical trial with a 2x2 factorial design.
Intervention
1. Use of the Travalert dosing aid
2. Use of the Travalert with the Eyot drop guider
3. Use of the Travalert together with patient education
4. Use of the Travalert and Eyot together with patient education
Study burden and risks
Glaucoma patients are requested to fill in several questionnaires. Furthermore,
they are asked to use the Travalert and 50% will also be using the Eyot which
may be very helpful for them. Fifty percent of patiens will receive patient
education by an assistant, which may also be beneficial for them. Follow-up
visits to the outpatient clinic will be scheduled at 3 and 6 months after
inclusion in the study. These visits closely reflect common practice in the
management of glaucoma. There are no risks involved for participating patients.
Avelingen-West 5 (Alcon Nederland)
4202 MS Gorinchem
Nederland
Avelingen-West 5 (Alcon Nederland)
4202 MS Gorinchem
Nederland
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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 | NL16962.068.07 |