Two Randomized, Double-masked, Placebo-controlled Studies of the Local Anesthetic Effect of Articaine Ophthalmic Solution.

ABSTRACT:

Background

We wanted to develop a new topical ocular anesthetic with good bioavailability in anterior segment tissues. Given concerns about contamination and sterility in multi-dose products, we selected a unit-dose, nonpreserved presentation of AG-920 (articaine ophthalmic solution) in blow-fill-seal containers (similar to currently marketed pharmacological therapies for dry eye disease).

Methods

Consistent with US Food and Drug Administration guidance, two pivotal, Phase 3, randomized, placebo-controlled, double-masked, parallel design studies conducted at two US private practices in 240 healthy subjects. A single dose of AG-920 or identical looking placebo into one (study) eye (2 drops 30 s apart). Subjects underwent a conjunctival pinch procedure and assessment of the pa

SUBMITTER: Gonzalez VH 

PROVIDER: S-EPMC10183183 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature