Corneal Diseases
Conditions
Brief 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.
Interventions
DRUGZKY001 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.
Sponsors
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
A dose group of 0.004% was used
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate pharmacokinetic parameters | Day 6 | Pharmacokinetic parameters（Area Under Curve from 0 to time t（AUC 0-t）） were estimated based on plasma concentration of ZKY001 after multiple dosing |
Countries
China
Outcome results
None listed