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

Phase 1CompletedNCT07132437

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.3 enrolled

Overview

One dose group of 0.004% was used.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Corneal Diseases

Interventions

ZKY001 EYE DROPSDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and women aged 18-70 (including threshold); 2. Body mass index between 19-26kg/m2 (including critical value), male weight ≥50kg, female weight ≥45kg; 3. Patients who have undergone Descemet's stripping endothelial keratoplasty（DSEK）, Descemet's stripping automated endothelial keratoplasty（DSAEK） or Descemet membrane endothelial keratoplasty（DMEK） and need to remove corneal epithelium during surgery (the diameter of the removed epithelium area ≥8mm); 4. Lacrimal secretion test (Schirmer test I) ≥10mm/5min during screening; 5. Limbus structure was normal under slit-lamp during screening period; 6. Voluntarily sign informed consent. Exclusion Criteria: 1. Smoking more than 5 cigarettes per day on average; 2. suspected or indeed alcohol dependence with an average intake of more than 2 units of alcohol per day for 3 months or positive alcohol test; 3. those who have a history of drug abuse or have a positive urine test;

Locations (1)

Zhiqiang Pan

Beijing, China