To demonstrate proof of concept, i.e. equivalent dispersal by both methods.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
n.v.t. onderzoek wordt verricht op gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Autofluorescence.
Secondary outcome
Treatment satisfaction score
Blinking reflex (qualitative assessment by investigator).
Background summary
Eye drops are frequently used for opthalmic drug delivery. An alternative
method by means of an ophthalmic spray device, ADE Fluorescein A, has been
developed for improved efficiency and convenience.
Study objective
To demonstrate proof of concept, i.e. equivalent dispersal by both methods.
Study design
Proof of concept, pilot study.
Intervention
Topical ocular administration of fluorescein by 1) conventional eye drops in
one eye versus 2) ADE Fluorescein A in the fellow eye.
Study burden and risks
Participation requires a single visit to the Rotterdam Eye Hospital which takes
about two hours. Participants do not benefit. Risks of topical fluorescein are
considered to be low. Autofluorescence measurement is a non-invasive procedure.
Burden is moderate.
Colosseum 23
7521 PV Enschede
NL
Colosseum 23
7521 PV Enschede
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers with healthy eyes.
Informed consent.
Age > 18 years.
Exclusion criteria
Allergy/hypersensitivity for fluorescein.
Previous ocular surgery, including refractive laser surgery.
Corneal condition (e.g. Sjögren, punctata).
Contact lens wear.
Active epithelial HSV keratitis.
Pregnancy.;Concurrent use of eye drops.
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 | NL39567.078.12 |