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

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.

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;