NCT06451666

Safety and Efficacy Study of Pilocarpine HCl Ophthalmic Solution in Participants With Presbyopia

A Phase 3, Multicenter, Double-Masked, Randomized, Vehicle-Controlled Study Evaluating the Safety and Efficacy of Pilocarpine HCl in Participants With Presbyopia

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine HCl ophthalmic solution when administered bilaterally, once daily for 30 days in participants with presbyopia.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	Pilocarpine HCl Ophthalmic Solution	Pilocarpine HCl ophthalmic solution 1.25%, one drop in each eye, once daily, for up to 30 days
DRUG	Vehicle	Vehicle, one drop in each eye, once daily, for up to 30 days.

Timeline

• Start date: 2024-06-30
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2024-06-11
• Last updated: 2024-07-03