A Phase 3 Efficacy Study of Pilocarpine HCl Ophthalmic Solution (AGN-190584) in Participants With Presbyopia

Summary

This clinical study will evaluate pilocarpine hydrogen chloride (HCl) ophthalmic solution (AGN-190584) in an expanded participant population to establish efficacy, safety, and tolerability versus the vehicle-control when administered, over a 30-day study intervention period, once daily bilaterally in participants with presbyopia.

Timeline

Start

2019-03-01

Primary completion

2020-09-10

Completion

2020-09-10

Outcome

Met primary endpoint

registry analysis (superiority test); Vehicle vs Pilocarpine HCl Ophthalmic Solution; p <.0001; Percentage Difference 15.2 (95% CI 7.7 to 22.7) NCT03857542 ↗

Drugs

Indications