Safety and Efficacy of AGN-190584 in Individuals With Presbyopia: The GEMINI 1 Phase 3 Randomized Clinical Trial.

ABSTRACT:

Importance

AGN-190584 (Allergan, an AbbVie company) is an optimized topical formulation of pilocarpine hydrochloride, 1.25%, designed for managing presbyopia and enhanced with a proprietary vehicle.

Objective

To evaluate the efficacy and safety of pilocarpine hydrochloride, 1.25%, in individuals with presbyopia.

Design, setting, and participants

This vehicle-controlled, participant- and investigator-masked, randomized, phase 3 clinical study, GEMINI 1, enrolled individuals with presbyopia, aged 40 to 55 years, at 36 sites in the United States from December 21, 2018, to October 31, 2019. Analysis took place between February 2020 and December 2021.

Interventions

AGN-190584 or the AGN-190584 formulation vehicle was administered bilaterally, once daily for 30 days.

SUBMITTER: Waring GO 

PROVIDER: S-EPMC8895317 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature