NCT05501860

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

A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Evaluation of the Ocular Safety of Articaine Sterile Topical Ophthalmic Solution

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: American Genomics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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..

Detailed 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.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	AG-920	AG-920 Sterile Topical Ophthalmic Solution
DRUG	Placebo	Placebo Sterile Topical Ophthalmic Solution

Timeline

• Start date: 2022-07-30
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2022-08-16
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study