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

April 9, 2008 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Hopital Robert Debre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.
Time Frame: 75 minutes
75 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Ioltech

Investigators

  • Principal Investigator: Dominique BREMOND GIGNAC, MD, Hôpital Robert Debré, APHP, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

February 1, 2008

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 21, 2008

First Posted (Estimate)

March 24, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 9, 2008

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P050308
  • réf Afssaps : 437-050883-LB/GG
  • Eudract : 2005-004418-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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