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Administration of Topical Ophthalmic Medication (ATOM): Feasibility of the spraynozzle technique.


- candidate number12276
- NTR NumberNTR3404
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-apr-2012
- Secondary IDs2010-04 / NL39567.078.12; Oogziekenhuis Rotterdam / CCMO
- Public TitleAdministration of Topical Ophthalmic Medication (ATOM): Feasibility of the spraynozzle technique.
- Scientific TitleAdministration of Topical Ophthalmic Medication (ATOM): Feasibility of the spraynozzle technique.
- ACRONYMATOM
- hypothesisOpthalmic 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) studiedOphthalmic drug dispersal
- Inclusion criteria1. Informed consent;
2. Age > 18 years.
- Exclusion criteria1. 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;
7. Pregnancy.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2012
- planned closingdate30-jun-2012
- Target number of participants20
- InterventionsTopical ocular administration of fluorescein by two different methods.
1. Conventional eye drops in one eye;
2. ADE Fluorescein A in fellow eye.
- Primary outcomeAutofluorescence of the cornea, anterior chamber, vitreous and retina.
- Secondary outcome1. Treatment satisfaction score (TSS);
2. Blinking reflex (qualitative assessment by investigator).
- TimepointsMeasurements will be performed before administration and at: 1, 2, 5, 10, 20, 50 and 100 minutes after administration.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES J. Rooij, van
- CONTACT for SCIENTIFIC QUERIES J. Rooij, van
- Sponsor/Initiator Medspray XMEMS BV
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Economic Affairs, Agriculture and Innovation, Medspray XMEMS BV, Provincies Gelderland en Overijssel
- PublicationsN/A
- Brief summaryRationale:
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.

Objective:
To demonstrate proof of concept, i.e. equivalent dispersal by both methods.

Study design:
Proof of concept, pilot study.

Study population:
Healthy volunteers with healthy eyes.

Intervention:
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:
Autofluorescence.

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)
- RECORD23-apr-2012 - 30-apr-2012


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