NCT04228926

Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of ZKY001 Eye Drops in Patients With Corneal Epithelial Defects After Corneal Endothelial Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The subjects of this study were patients who underwent corneal endothelial transplantation,who were randomly divided into 3 groups, 2 groups (0.002% and 0.004% ZKY001 eye drops) and 1 placebo control group.

Detailed description

This study is an exploratory phase II clinical study with no sample size estimation.According to the results of the preliminary animal experiments and phase I clinical trials, 2 concentrations (0.002% and 0.004%ZKY001eye drops) were selected as the experimental group, and 1 placebo control group was selected, with 35 subjects in each group and a total of 105 subjects.Each subject will drop the study drug into the test eye (the surgical eye is taken as the test eye) according to the randomly assigned drug number.

Conditions

• Corneal Defect

Interventions

Type	Name	Description
DRUG	ZKY001 eye drops 0.3g:0.006mg	ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation
DRUG	ZKY001 eye drops 0.3g:0.012mg	ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation
DRUG	ZKY001 simulated eye drops	ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation

Timeline

• Start date: 2020-12-24
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2020-01-14
• Last updated: 2021-09-17

Locations

1 site across 1 country: China