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NOT YET RECRUITING
NCT06451666
PHASE3

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

Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2024-06-30

Completion Date

2025-12-30

Last Updated

2024-07-03

Healthy Volunteers

No

Conditions

Interventions

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.