An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920

Phase 1 Completed 14 enrolled American Genomics, LLC

NaSingle-groupOpen-labelBasic science

Summary

This is a Phase 1, open-label, non-comparative study in healthy subjects performed in the US. It is designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye.

Timeline

Start: 2021-02-24
Primary completion: 2021-02-25
Completion: 2021-02-25

Publications

Verhoeven R, Uram M, Schupp A, Rasmussen S, Widmann M, Novack GD. Early Nonclinical and Clinical Development of AG-920, a Repurposed Topical Ocular Anesthetic. J Ocul Pharmacol Ther. 2022 Sep;38(7):481-488. doi: 10.1089/jop.2022.0026. Epub 2022 Jul 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Articaine	Other / unclassified	8 %	Topical

Indications

No indication recorded.