Overview

CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment

Status:
Terminated
Trial end date:
2008-06-01
Target enrollment:
0
Participant gender:
All
Summary
Pupillary dilation to perform a fundus in premature newborns and neonates is often difficult to obtain, because of the non mature iris sphincter. The fundus is essential to detect retinal anomalies (as retinopathy of prematurity or chorioretinal or disk anomalies). The aim of the study is to obtain a satisfactory degree of mydriasis with a minimal dose of two mydriatic treatments, with an optimal duration and a good tolerance of the drugs. The study will evaluate the mydriasis in premature newborns, neonates and infants justifying a mydriasis for a bilateral diagnosis fundus, using ophthalmic insert Mydriasert® versus reference treatment (association of phenylephrine and tropicamide eyedrops). Ophthalmic insert Mydriasert® can control drug dispensation and decrease the number of nurse interventions to obtain mydriasis in patients.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Ioltech
Treatments:
Ophthalmic Solutions
Oxymetazoline
Phenylephrine
Tetrahydrozoline
Tropicamide
Criteria
Inclusion Criteria:

- Premature newborns, neonates and infants of less 18 months-old indoor in the
neonatology clinical department of Robert Debre Hospital with cardiologic monitoring

- Presenting a risk of retinopathy of prematurity or fundus anomaly (chorioretinal
and/or disk anomalies).

- Needing a bilateral fundus

- Parents, tutor or legal representing of the patient had been informed of objectives of
the study and had given their written consent.

- Covered by French social security or CMU

Exclusion Criteria:

- Neonates of less 1000g at inclusion

- Premature newborn of less 30 weeks of gestational age at inclusion

- Contra-indication to one of the evaluated drugs

- Any treatment that could provoke a dangerous drug interaction for the patient if
associated with one of the drug of the study

- Anatomical predisposition to glaucoma, hypertension or any other contra-indication
noted by the physician