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

Sponsor:	Assistance Publique - Hôpitaux de Paris
Collaborator:	Ioltech
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00642135

Purpose

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.

Condition	Intervention	Phase
Retinal Anomalies Premature Birth	Drug: Mydriasert® Drug: phenylephrine and tropicamide eyedrops	Phase III

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

Resource links provided by NLM:

Drug Information available for: Phenylephrine Phenylephrine hydrochloride Tetrahydrozoline Tetrahydrozoline hydrochloride Oxymetazoline Tropicamide Oxymetazoline hydrochloride

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	80
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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®

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

Ages Eligible for Study:	up to 18 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642135

Locations

France
Hôpital Robert Debré
Paris, France, 75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Ioltech

Investigators

Principal Investigator:

Dominique BREMOND GIGNAC, MD

Hôpital Robert Debré, APHP, France

More Information

No publications provided

Responsible Party:	Mathieu QUINTIN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00642135 History of Changes
Other Study ID Numbers:	P050308, réf Afssaps : 437-050883-LB/GG, Eudract : 2005-004418-33
Study First Received:	March 17, 2008
Last Updated:	April 9, 2008
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

premature
neonates
infants
children
Mydriasert®
mydriasis
fundus

Tropicamide
Phenylephrine
clinical trial
Infant
premature newborns
bilateral diagnosis fundus

Additional relevant MeSH terms:

Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Tetrahydrozoline
Phenylephrine
Oxymetazoline
Tropicamide
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Sympathomimetics

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cardiotonic Agents
Mydriatics
Protective Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 12, 2012