|- candidate number||12276|
|- NTR Number||NTR3404|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-apr-2012|
|- Secondary IDs||2010-04 / NL39567.078.12; Oogziekenhuis Rotterdam / CCMO|
|- Public Title||Administration of Topical Ophthalmic Medication (ATOM): Feasibility of the spraynozzle technique.|
|- Scientific Title||Administration of Topical Ophthalmic Medication (ATOM): Feasibility of the spraynozzle technique.|
|- hypothesis||Opthalmic drug delivery by means of the ophthalmic spray device, ADE Fluorescein A, is equivalent to conventional eye drops with respect to drug dispersal.|
|- Healt Condition(s) or Problem(s) studied||Ophthalmic drug dispersal|
|- Inclusion criteria||1. Informed consent;|
2. Age > 18 years.
|- Exclusion criteria||1. Allergy/hypersensitivity for fluorescein;|
2. Previous ocular surgery, including refractive laser surgery;
3. Corneal condition (e.g. Sjögren, punctata);
4. Contact lens wear;
5. Concurrent use of eye drops;
6. Active epithelial HSV keratitis;
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2012|
|- planned closingdate||30-jun-2012|
|- Target number of participants||20|
|- Interventions||Topical ocular administration of fluorescein by two different methods.|
1. Conventional eye drops in one eye;
2. ADE Fluorescein A in fellow eye.
|- Primary outcome||Autofluorescence of the cornea, anterior chamber, vitreous and retina.|
|- Secondary outcome||1. Treatment satisfaction score (TSS);|
2. Blinking reflex (qualitative assessment by investigator).
|- Timepoints||Measurements will be performed before administration and at: 1, 2, 5, 10, 20, 50 and 100 minutes after administration.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| J. Rooij, van|
|- CONTACT for SCIENTIFIC QUERIES|| J. Rooij, van|
|- Sponsor/Initiator ||Medspray XMEMS BV|
(Source(s) of Monetary or Material Support)
|Ministry of Economic Affairs, Agriculture and Innovation, Medspray XMEMS BV, Provincies Gelderland en Overijssel|
|- Brief summary||Rationale:|
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.
To demonstrate proof of concept, i.e. equivalent dispersal by both methods.
Proof of concept, pilot study.
Healthy volunteers with healthy eyes.
Topical ocular administration of fluorescein by:
1. Conventional eye drops in one eye versus;
2. ADE Fluorescein A in the fellow eye.
Main study parameters:
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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.
|- Main changes (audit trail)|
|- RECORD||23-apr-2012 - 30-apr-2012|