NCT05114486

Safety & Efficacy of Pilocarpine Ophthalmic Spray for Temporary Improvement of Near Vision in Presbyopic Adults

A Phase 3 Study of the Safety and Efficacy of 2% Pilocarpine Ophthalmic Spray Administered With the Optejet® Microdose Dispenser for Temporary Improvement of Near Vision in Adults With Presbyopia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Eyenovia Inc. · Industry
• Sex: All
• Age: 40 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Volunteer participants are evaluated for eligibility during a Screening Visit; those meeting study inclusion/exclusion criteria are scheduled for 2 treatment visits. At each treatment visit, 1 of the 2 study treatments is self-administered to both eyes. Afterwards, efficacy and safety assessments are performed over a 3-hour period.

Conditions

• Presbyopia

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Pilocarpine Ophthalmic administered with the Optejet dispenser	Pilocarpine 2% ophthalmic spray administered with the Optejet dispenser
COMBINATION_PRODUCT	Placebo administered with the Optejet dispenser	Vehicle ophthalmic solution administered with the Optejet dispenser

Timeline

• Start date: 2021-11-03
• Primary completion: 2022-09-20
• Completion: 2022-09-20
• First posted: 2021-11-10
• Last updated: 2023-09-11

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study