Clinical Trial: CLAIR -FO: Clinical Trial of Ophthalmic Insert Mydriasert® Versus Reference Treatment
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Efficacy and Tolerance of Ophthalmic Insert Mydriasert® Versus Reference Treatment (Phenylephrine and Tropicamide Eyedrops) in Premature Newborns, Neonates and Infants Justifying a
Current Secondary Outcome:
- Frequency of the nurse intervention to obtain the mydriasis [ Time Frame: during 215 minutes maximum ]
- Calculation of the dose of active drugs administrated [ Time Frame: one day ]
- Local and systemic clinical tolerance [ Time Frame: one day ]
- Occurrence of adverse reactions [ Time Frame: one day ]
- Stability of a mydriasis of good quality at T+195 [ Time Frame: at T+195 minutes ]
Original Secondary Outcome: Same as current
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: March 17, 2008
Date Started: January 2006
Date Completion: June 2008
Last Updated: April 9, 2008
Last Verified: January 2006