Obiettivi del progettoPrimary objective Equivalence evaluation of Test versus Reference products in terms of proportion of subjects with a successful surface anesthesia for cataract surgery, without any supplementation (see definitions below) at T4(just before Intra Ocular Lens implantation) Successful surface anesthesia: The patient assessment of ocular discomfort during surgery must be 0 (=No pain or discomfort) or 1 (=Occasional pressure sensation, less than 5 separated times during procedure) without any supplementation at T4. Supplementation:Intra-operative analgesia, including additional LA drops administration,after the beginning of the surgery. Secondary objective Assess the clinical efficacy and safety of 3% chloroprocaine gel compared to those of tetracaine 0.5% eye drop. |
Data di inizio e fine |
Novembre 2020 - Marzo 2021 |
Responsabile del progetto |
Stefano Bonini - Principal Investigator Marco Coassin Antonio DI Zazzo Roberto Sgrulletta |
Istituzione coordinatrice del progetto |
PUCBM |
Fonte/i di finanziamento |
• Finanziamento Azienda farmaceutica
Link al sito del progettoClinical Trials register - Search for eudract_number:2019-001660-30 |