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

NCT ID: NCT00642135

Last Updated: 2008-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Retinal Anomalies Premature Birth

Keywords

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premature neonates infants children Mydriasert® mydriasis fundus Tropicamide Phenylephrine clinical trial Infant premature newborns bilateral diagnosis fundus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops

Group Type ACTIVE_COMPARATOR

phenylephrine and tropicamide eyedrops

Intervention Type DRUG

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

2

Premature newborns and neonates treated using insert Mydriasert®

Group Type ACTIVE_COMPARATOR

Mydriasert®

Intervention Type DRUG

Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

Interventions

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Mydriasert®

Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

Intervention Type DRUG

phenylephrine and tropicamide eyedrops

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

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ioltech

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Department Clinical Research of Developpement

Principal Investigators

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Dominique BREMOND GIGNAC, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Robert Debré, APHP, France

Locations

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Hôpital Robert Debré

Paris, , France

Site Status

Countries

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France

Other Identifiers

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réf Afssaps : 437-050883-LB/GG

Identifier Type: -

Identifier Source: secondary_id

Eudract : 2005-004418-33

Identifier Type: -

Identifier Source: secondary_id

P050308

Identifier Type: -

Identifier Source: org_study_id