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

Premature Birth Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00642135
• Other study ID #: P050308
• Secondary ID: réf Afssaps : 43
• Status: Terminated
• Phase: Phase 3
• First received: March 17, 2008
• Last updated: April 9, 2008
• Start date: January 2006
• Est. completion date: June 2008

Study information

• Verified date: January 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Months

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Premature Birth
• Retinal Anomalies

Intervention

Drug:
• Mydriasert®
Premature newborns and neonates treated using ophthalmologic insert Mydriasert®
• phenylephrine and tropicamide eyedrops
Premature newborns and neonates treated using reference treatment (association of Phenylephrine and tropicamide eyedrops)

Locations

Country	Name	City	State
France	Hôpital Robert Debré	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ioltech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mydriasis larger than 5,5 mm with absence of photometer reflex to get a satisfactory fundus.		75 minutes	No
Secondary	Frequency of the nurse intervention to obtain the mydriasis		during 215 minutes maximum	No
Secondary	Calculation of the dose of active drugs administrated		one day	No
Secondary	Local and systemic clinical tolerance		one day	Yes
Secondary	Occurrence of adverse reactions		one day	Yes
Secondary	Stability of a mydriasis of good quality at T+195		at T+195 minutes	No