NCT04513652

A Study of the Safety and Anesthetic Effect of AG-920 Topical Ophthalmic Solution

A Randomized, Double-Masked, Vehicle-Controlled, Parallel Evaluation of the Local Anesthetic Effect of Articaine Sterile Topical Ophthalmic Solution

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: American Genomics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution.

Detailed description

This is a Phase 3, randomized, placebo-controlled, double masked, parallel design study in healthy subjects performed in the US. It is designed to evaluate the safety and anesthetic efficacy of AG-920 Sterile Topical Ophthalmic Solution. 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 1:1 ratio to receive a single dose of AG-920 or identical looking placebo into the study eye. Subjects will undergo a conjunctival pinch procedure and the pain associated with the pinch rated.

Conditions

• Anesthesia, Local

Interventions

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

Timeline

• Start date: 2020-09-03
• Primary completion: 2020-09-30
• Completion: 2020-12-17
• First posted: 2020-08-14
• Last updated: 2022-09-28
• Results posted: 2022-09-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study