Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.

Summary

Randomized clinical trial, multicenter, two-armed, to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anestheticsin phacoemulsification. This prospective, observer masked, randomised, controlled, equivalence phase 3 study will be conducted in approximately 4 European Countries. Sintetica intends to perform a phase 3 study on patients undergoing cataract surgery to assess the safety and efficacy of topical anaesthesia using chloroprocaine gel.

Timeline

Start

2020-09-09

Primary completion

2021-03-01

Completion

2021-03-09

Outcome

Met primary endpoint

paper Equivalence was demonstrated, with a somewhat higher success rate of chloroprocaine gel: PMID 38489057 ↗

paper 90% CI fell within (-10 to 10). PMID 38489057 ↗

Publications

• Figus M, Giansanti F, Villani E, Alio JL, Janco L, Mercuri S, Camnasio S, Cagini C. Chloroprocaine 3% Gel as a Novel Ocular Topical Anesthetic: Results from a Multicenter, Randomized Clinical Trial in Patients Undergoing Cataract Surgery. J Ocul Pharmacol Ther. 2024 Mar;40(2):117-125. doi: 10.1089/jop.2023.0096.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Chloroprocaine	Other / unclassified	3 %	Topical
Comparator	tetracaine	Other / unclassified	0.5 %	Topical

Indications