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

Information source: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Retinal Anomalies; Premature Birth

Intervention: Mydriasert® (Drug); phenylephrine and tropicamide eyedrops (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Assistance Publique - Hôpitaux de Paris

Official(s) and/or principal investigator(s):
Dominique BREMOND GIGNAC, MD, Principal Investigator, Affiliation: Hôpital Robert Debré, APHP, France

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.

Secondary outcome:

Frequency of the nurse intervention to obtain the mydriasis

Calculation of the dose of active drugs administrated

Local and systemic clinical tolerance

Occurrence of adverse reactions

Stability of a mydriasis of good quality at T+195

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.

Eligibility

Minimum age: N/A. Maximum age: 18 Months. Gender(s): Both.

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

Locations and Contacts

Hôpital Robert Debré, Paris 75019, France
Additional Information

Starting date: January 2006
Last updated: April 9, 2008

Page last updated: August 23, 2015

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