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 mydriasisCalculation 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
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