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

Phase 3 Completed 61 enrolled American Genomics, LLC

RandomizedParallel-groupSingle-blindSupportive care

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.

Timeline

Start: 2022-04-06
Primary completion: 2022-05-27
Completion: 2022-05-27

Outcome

Met primary endpoint

paper In all subjects in each treatment group, the investigator was able to perform the eye examination without additional local anesthetic. PMID 38647654 ↗

paper AG-920 was therapeutically equivalent to marketed proparacaine with respect to having an ophthalmic examination performed without needing additional local anesthetic. PMID 38647654 ↗

Publications

Gonzalez VH, Uram M, Schupp A, Widmann M, Novack GD. AG-920 (Articaine) Ophthalmic Solution: A Masked, Active-Controlled Evaluation of Its Local Anesthetic Efficacy and Safety in Pediatric Patients. J Ocul Pharmacol Ther. 2024 Jun;40(5):293-296. doi: 10.1089/jop.2023.0187. Epub 2024 Apr 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AG-920	Unknown	8 %	Topical
Comparator	Proparacaine	Other / unclassified	0.5 %	—

Indications

No indication recorded.