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

Tracking Information

First Received Date ^ICMJE

March 17, 2008

Last Updated Date

April 9, 2008

Start Date ^ICMJE

January 2006

Estimated Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus. [ Time Frame: 75 minutes ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00642135 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Frequency of the nurse intervention to obtain the mydriasis [ Time Frame: during 215 minutes maximum ] [ Designated as safety issue: No ]
Calculation of the dose of active drugs administrated [ Time Frame: one day ] [ Designated as safety issue: No ]
Local and systemic clinical tolerance [ Time Frame: one day ] [ Designated as safety issue: Yes ]
Occurrence of adverse reactions [ Time Frame: one day ] [ Designated as safety issue: Yes ]
Stability of a mydriasis of good quality at T+195 [ Time Frame: at T+195 minutes ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Retinal Anomalies
Premature Birth

Intervention ^ICMJE

Drug: Mydriasert®
Drug: phenylephrine and tropicamide eyedrops

Study Arms / Comparison Groups

Active Comparator: Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
Active Comparator: Premature newborns and neonates treated using insert Mydriasert®

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Estimated Completion Date

June 2008

Estimated Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 18 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00642135

Responsible Party

Mathieu QUINTIN, Department Clinical Research of Developpement

Study ID Numbers ^ICMJE

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

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Ioltech

Investigators ^ICMJE

Principal Investigator:

Dominique BREMOND GIGNAC, MD

Hôpital Robert Debré, APHP, France

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP