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

NCT00642135 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-04-10

No results posted yet for this study

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.

Conditions

  • Retinal Anomalies
  • Premature Birth

Interventions

DRUG

Mydriasert®

Premature newborns and neonates treated using ophthalmologic insert Mydriasert®

DRUG

phenylephrine and tropicamide eyedrops

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

Sponsors & Collaborators

  • Ioltech

    collaborator INDUSTRY

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Dominique BREMOND GIGNAC, MD · Hôpital Robert Debré, APHP, France

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-02-29
Completion
2008-06-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00642135 on ClinicalTrials.gov