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A Study of Safety and the Local Anesthetic Effect of AG-920 Ophthalmic Solution in a Pediatric Population

NCT05325853 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-10-25

Study results available
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Summary

A Phase 3, randomized, active-controlled, study in pediatric subjects. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 ophthalmic solution compared to Proparacaine Hydrochloride Ophthalmic Solution.

Conditions

  • Anesthesia, Local

Interventions

DRUG

AG-920

AG-920 Sterile Topical Ophthalmic Solution

DRUG

Proparacaine Ophthalmic

0.5% Proparacaine Hydrochloride

Sponsors & Collaborators

  • American Genomics, LLC

    lead INDUSTRY

Principal Investigators

  • Martin Uram, MD · Medical Expert

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2022-05-27
Completion
2022-05-27
FDA Drug
Yes

Countries

  • United States

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 NCT05325853 on ClinicalTrials.gov