Overview

Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population

Status:
Not yet recruiting

Trial end date:
2024-12-31

Target enrollment:

Participant gender:

Summary

The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients. 74 Participants (male and female, aged 0-17 yrs) will be 1:1 randomized for receiving either the test drug (Chloroprocaine) or the reference drug (Oxybuprocaine) before undergoing to ocular exam who needs ocular surface anesthesia. The successful surface anesthesia will be evaluated 5 minutes after receiving 2 drops (1 minute apart) of either test or reference drug by an eye spear sponge

Phase:

Phase 3

Details

Lead Sponsor:

Sintetica SA

Collaborator:

Cross Research S.A.

Treatments:

Benoxinate
Chloroprocaine
Ophthalmic Solutions