NCT06213727

ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Phase Ⅱ Clinical Trial

To Evaluate the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects in a Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ⅱ Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. The study included two experimental groups (low-dose ZKY001 eye drops group and medium-dose ZKY001 eye drops group) and a placebo control group, with 60 subjects in each group.

Detailed description

Each subject had the study drug instilled into the study eye according to the randomly obtained drug number. Duration OF THE STUDY：The screening period was D-5 to D-1, the experimental period was D0 (the day of operation) to D5, and the observation period was D10±2. Statistical analyses were performed with the use of SAS software (version 9.4 or higher) without special instructions. All statistical tests were two-sided, with a significance level of 0.05. Enrollment analysis: the number of enrolled and completed cases in each center was summarized, and the list of dropped cases was made. Overall dropout rates in each group and dropout rates related to adverse events were compared between groups with the use of the chi-square test or Fisher's exact test.

Conditions

• Corneal Epithelial Defect

Interventions

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

Timeline

• Start date: 2022-03-15
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2024-01-19
• Last updated: 2024-01-19

Locations

1 site across 1 country: China