Dettagli per singolo studio

DEC-NET Serial number FR578

Published online	12/10/2006 11.03.00
Last updated	12/10/2006 11.02.49

Other protocol ID number	N/A
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	MYDRIASIS (PERSISTENT) NOT DUE TO MYDRIATICS
Experimental drug
TROPICAMIDE, COMBINATIONS Treatment regimen (dosage and duration) An insert is placed in the conjunctival fornix of each eye at time 0 and withdrawed at T70 minutes.
Control drug
TROPICAMIDE COMBINATIONS Treatment regimen (dosage and duration) A drop instillation of Tropicamide and Phenylephrine is made in each eye 3 times at 10 mn of interval (T0 T10 and T20)
Gender	Both
Age (range)	Premature to newborn
Eligibility criteria
Inclusion criteria
-Premature and infants hospitalized in the Neonatology Unit of the Robert Debré hospital and being under cardiac monitoring -Presenting a retinopathy risk of prematurity or a risk of ocular abnormalities in the eyeground: chorio-retinal and/or papillary -Written consent of parent.
Exclusion criteria
-New-born baby of less 1000g and less than 30 weeks corrected age -Contraindication with the one of the evaluated drugs.
Trial design/methodology
Phase	3
Kind of study	Efficacy Bioequivalence Safety
Design	Controlled Randomised Blinded Double blind
Purpose of study
Principal objective: -To compare the percentage of mydriase of quality allowing the realization of the eyeground obtained by mydriasert versus recommended treatment(tropicamide and phenylephrine). Secondary objectives: -To compare between the two groups of treatment: 1/frequency of intervention of the nurse to treat the patient until obtaining the mydriase. 2/respect of the time designed to obtain a mydriase allowing the reading of the eyeground 3/calcul of the dosage of active drug received 4/local clinical tolerance in particular cardiac 5/adverse effects 6/stability of the mydriase defined by a mydriase of good quality maintained at the time of measurement in T+180mn.
Primary outcomes
-obtaining a premium mydriasis (success)
Secondary outcomes
-The frequency of intervention to treat the patient until obtaining mydriasis -Time measured to have a satisfactory eyeground -received theoretical doses (mg) of tropicamide and phenylephrine -The local and systemic clinical tolerance (cardiac) -Appearance of side effects -Mydriasis stability
Summary of study design, objectives, and ongoing research findings
Equivalence, randomized and blinded study. Newborns requiring an eyeground examination are included. Primary objective is to compare the quality of the mydriasis obtained by Mydriasert versus the reference treatment(Phenylephrine and tropicamide).