A Safety Study of of AG-920 Sterile Topical Ophthalmic Solution

Status Completed

Clinical Trial Summary

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects. It is designed to evaluate the ocular safety of a single topical ocular administration of AG-920 sterile topical ophthalmic solution compared to placebo..

Clinical Trial Description

A Phase 3, randomized, placebo-controlled, double-masked, parallel study in healthy subjects performed in the US. It is designed to evaluate the ocular safety of one dose of AG-920 compared to placebo. I). In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 2:1 ratio to receive one dose of AG-920 or identical looking placebo into one (study) eye. A subset of subjects will undergo endothelial cell count (ECC) evaluations. Each dose of AG-920 or placebo will consist of two drops in the study eye. After the completion of dosing, subjects will undergo a series of eye exams that will be documented. Investigational medicinal product (IMP) dosing will be performed by the study staff. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05501860
Study type	Interventional
Source	American Genomics, LLC
Contact
Status	Completed
Phase	Phase 3
Start date	July 30, 2022
Completion date	December 7, 2022

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