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

Corneal Defect Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Corneal Defect

Clinical Trial Details

NCT number	NCT04228926
Study type	Interventional
Source	Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Contact	Xiuli Zhao, PHD
Phone	010-58268486
Email	xiulizhao@medmail.com.cn
Status	Recruiting
Phase	Phase 2
Start date	December 24, 2020
Completion date	December 31, 2021

View Details

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