NCT05325853

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

A Randomized, Single-Masked, Active-Controlled, Parallel-Group Evaluation of Safety and the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution (AG-920) in a Pediatric Population

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: American Genomics, LLC · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

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.

Detailed description

A Phase 3, randomized, active-controlled, single-masked, parallel-group design study in pediatric subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of one dose of AG-920 compared to Proparacaine. In this study, parent/legal guardians will provide informed consent (and where applicable, subjects will provide assent). Subjects who fulfill all the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to receive a single dose of AG 920 or Proparacaine into one (study) eye. Each dose of AG-920 or Proparacaine HCl will consist of two drops in the study eye. After the completion of dosing, subjects will undergo an eye exam, and the ability to conduct that eye exam 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	Proparacaine Ophthalmic	0.5% Proparacaine Hydrochloride

Timeline

• Start date: 2022-04-06
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2022-04-13
• Last updated: 2023-10-25
• Results posted: 2023-10-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study