NCT06209203

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients with Corneal Epithelial Defects After TPRK

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.

Detailed description

Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7. Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.

Conditions

• Corneal Epithelium Defect

Interventions

Type	Name	Description
DRUG	lowe-dose ZKY001 eye drops	eye drops
DRUG	Medium-dose ZKY001 eye drops	eye drops
DRUG	placebo	eye drops

Timeline

• Start date: 2022-08-03
• Primary completion: 2022-11-08
• Completion: 2022-11-08
• First posted: 2024-01-17
• Last updated: 2025-01-15

Locations

1 site across 1 country: China