The new drug delivery device is a rod-shaped metal bar, called an ocular coil. The coil can be loaded with one (or more) drug(s) en can be placed easily in the lower eyelid of the eye. In this way, the drug can be released to the eye in a constant…
ID
Source
Brief title
Condition
- Eye disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is the evaluation of the safety of the ocular coil.
Secondary outcome
Secondary objectives are coil retention (duration), subject comfort (tolerance)
and incidence of adverse effects and complications.
Background summary
Current ocular drug delivery systems, such as eye drops and ointments, suffer
from low bioavailability of the drug, a very short duration of action, initial
high drug concentrations, considerable systemic absorption of the drug and
difficulty to instil eye drops or ointments. In addition, patient compliance
(the degree to which a patient correctly adheres to the directions for use of a
medical advice) is low with eye drops and ointments due to high frequency of
administration. Due to these shortcomings, ocular diseases are not being
treated adequately and may further progress and lead to blindness.
Study objective
The new drug delivery device is a rod-shaped metal bar, called an ocular coil.
The coil can be loaded with one (or more) drug(s) en can be placed easily in
the lower eyelid of the eye. In this way, the drug can be released to the eye
in a constant and sustained way.
Study design
In this phase of the research, the coil will not be loaded with drugs. The coil
will be placed in the lower eyelid of one eye. Afterwards, the comfort and
safety of the coil will be evaluated. The contralateral eye will serve as
control eye. Before and after insertion of the coil, both eyes will be
investigated by several ophthalmologic examinations. In addition, the
volunteers will be asked to complete questionnaires related to the comfort of
the coil in the eye.
The coil will be inserted in the eye for 4 weeks (day and night). During this
period, the eyes will be frequently examined (30 min per check-up). The
volunteers will receive a follow-up scheme for each check-up. The check-ups
will be performed at 30 min, 8 hours, 24, 48 hours and 1, 2, 3, 4 week after
insertion of the coil (total = 9 check-ups). The volunteers are expected to be
present at each check-up. We expect that wearing the coil will not influence
the daily life of the volunteers.
Study burden and risks
This following risks are associated with participation of the study:
* Irritation of the eye
* Infection of the eye
Peter Debyelaan 25
Maastricht 6229 HX
NL
Peter Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
* Age between 18 and 75 years old
* Informed and having given informed consent
* Willing and able to comply with scheduled visits and other study procedures
* If wearing contact lenses, willing to replace them for glasses for the duration of the study
Exclusion criteria
* Subjects with a history of eye disease
* Subjects using eye drops (during the study).
* Subjects with an Oriental/Asian lid crease, because of their narrow fornix.
* Subjects who do not speak and/or write Dutch properly.
* Subjects with a history of serious adverse reaction or hypersensitivity
- Subjects with hay fever
* Women who are pregnant or nursing their child, or have the intention to become pregnant during the course of the study.
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 |
|---|---|
| ClinicalTrials.gov | NCT03488017 |
| CCMO | NL57050.068.16 |