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

Zhaoke Ophthalmology

Status and phase: Completed; Phase 1

Conditions: Corneal Diseases

Treatments: Drug: ZKY001 EYE DROPS

Study type: Interventional

Funder types: Industry

Identifiers

NCT07132437

ZKYK-ZKY001-DYD

Details and patient eligibility

About

One dose group of 0.004% was used.

Full description

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

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

0.004% ZKY001 eye drops

Experimental group

Description:

Start taking the medicine from Day 1 and continue for 6 consecutive days.

Treatment:

Drug: ZKY001 EYE DROPS