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

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Terminated

CT.gov ID

NCT00642135

Collaborator

Ioltech (Industry)

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Anomalies Premature Birth	Drug: Mydriasert® Drug: phenylephrine and tropicamide eyedrops	Phase 3

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Efficacy and Tolerance of Ophthalmic Insert Mydriasert® Versus Reference Treatment (Phenylephrine and Tropicamide Eyedrops) in Premature Newborns, Neonates and Infants Justifying a Mydriasis for a Bilateral Diagnosis Fundus

Study Start Date :

Jan 1, 2006

Anticipated Primary Completion Date :

Feb 1, 2008

Anticipated Study Completion Date :

Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops	Drug: phenylephrine and tropicamide eyedrops Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)
Active Comparator: 2 Premature newborns and neonates treated using insert Mydriasert®	Drug: Mydriasert® Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

Arm

Intervention/Treatment

Active Comparator: 1

Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops

Drug: phenylephrine and tropicamide eyedrops

Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)

Active Comparator: 2

Premature newborns and neonates treated using insert Mydriasert®

Drug: Mydriasert®

Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

Outcome Measures

Primary Outcome Measures

Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus. [75 minutes]

Secondary Outcome Measures

Frequency of the nurse intervention to obtain the mydriasis [during 215 minutes maximum]
Calculation of the dose of active drugs administrated [one day]
Local and systemic clinical tolerance [one day]
Occurrence of adverse reactions [one day]
Stability of a mydriasis of good quality at T+195 [at T+195 minutes]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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