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

NCT05926258 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-03-09

Study results available
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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

DRUG

Chloroprocaine 3% eye gel

ocular surface anesthesia

DRUG

Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops

ocular surface anesthesia

Sponsors & Collaborators

  • Cross Research S.A.

    collaborator INDUSTRY

  • Sintetica SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2025-03-13
Completion
2025-03-13

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926258 on ClinicalTrials.gov