NCT06948357

Efficacy and Safety of BRIMOCHOL PF and CARBACHOL PF in Chinese Presbyopia Patients

A Multicenter, Randomized, Double-Blind, Crossover, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of BRIMOCHOL PF, CARBACHOL PF in Chinese Patients With Presbyopia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (estimated)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-Blind, crossover, placebo-controlled Phase II clinical Study to evaluate the efficacy and safety of BRIMOCHOL PF and CARBACHOL PF in the treatment of Chinese patients with presbyopia.

Detailed description

119 subjects were planned to be enrolled in this study and randomly assigned in equal proportions into 7 treatment sequences. Each subject will receive a total of 7 treatments, each treatment period will be 1 day, and two adjacent visits during the treatment period need to be eluted for at least 3 days。 The study period included the screening period (Day 14\~Day 1) with 1 visit and the treatment period (Day 0\~Day 30) with 7 visits. There were a total of 8 visits in this study, with a duration of 32 to 45 days.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DRUG	BRIMOCHOL PF eye drops; CARBACHOL PF eye drops; Brimonidine eye drops; Placebo	BRIMOCHOL PF eye drops, CARBACHOL PF eye drops, Brimonidine eye drops and Placebo were administered in 7 treatment sequences in various combinations and doses

Timeline

• Start date: 2025-03-24
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2025-04-29
• Last updated: 2025-04-29

Locations

1 site across 1 country: China