A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemulsification

Obiettivi del progetto

Primary 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


Fonte/i di finanziamento

• Finanziamento Azienda farmaceutica

Link al sito del progetto

Clinical Trials register - Search for eudract_number:2019-001660-30