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 Same as current

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