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

This study has been terminated.
(The total number of patients has been reached.)
Sponsor:
Collaborator:
Ioltech
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00642135
First received: March 17, 2008
Last updated: April 9, 2008
Last verified: January 2006

March 17, 2008
April 9, 2008
January 2006
February 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00642135 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Retinal Anomalies
  • Premature Birth
  • 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)
  • Active Comparator: 1
    Premature newborns and neonates treated using Phenylephrine and tropicamide eyedrops
    Intervention: Drug: phenylephrine and tropicamide eyedrops
  • Active Comparator: 2
    Premature newborns and neonates treated using insert Mydriasert®
    Intervention: Drug: Mydriasert®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
June 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
up to 18 Months
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00642135
P050308, réf Afssaps : 437-050883-LB/GG, Eudract : 2005-004418-33
Yes
Mathieu QUINTIN, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Ioltech
Principal Investigator: Dominique BREMOND GIGNAC, MD Hôpital Robert Debré, APHP, France
Assistance Publique - Hôpitaux de Paris
January 2006

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