NCT07132437

Phase I Clinical Study of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defect

Phase I Clinical Study of Systemic Pharmacokinetics and Safety of ZKY001 Eye Drops for Multiple Administration in Patients With Corneal Epithelial Defect After Corneal Endothelial Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

One dose group of 0.004% was used.

Detailed description

One dose group of 0.004% was used. The whole study includes two stages: pre-test and formal test.

Conditions

• Corneal Diseases

Interventions

Type	Name	Description
DRUG	ZKY001 EYE DROPS	On the 1st postoperative day (Day1), ZKY001 eye drops were dropped into the experimental eyes (the operative eyes were taken as the experimental eyes). ZKY001 eye drops were given at 8:00 am ±1h from Day1 to Day5. 4 times a day, 1 drop each time, recommended interval of 4 to 6 hours. Day6 was administered at 8:00 am ±1h, and ZKY001 eye drops were dropped into the test eye (the surgical eye was taken as the test eye). Day6 was given only once, 1 drop each time.

Timeline

• Start date: 2021-12-29
• Primary completion: 2022-05-17
• Completion: 2022-05-17
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

1 site across 1 country: China