NCT05926258

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

A Prospective, Observer-blind, Randomized Clinical Trial to Investigate and Compare the Clinical Efficacy of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia for Clinical Practice in Pediatric Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Sintetica SA · Industry
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Local Anesthetic

Interventions

Type	Name	Description
DRUG	Chloroprocaine 3% eye gel	ocular surface anesthesia
DRUG	Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops	ocular surface anesthesia

Timeline

• Start date: 2024-05-23
• Primary completion: 2025-03-13
• Completion: 2025-03-13
• First posted: 2023-07-03
• Last updated: 2026-03-09
• Results posted: 2026-03-09

Locations

3 sites across 1 country: Italy