CompletedPhase 1

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

China3 participantsStarted 2021-12-29

Plain-language summary

One dose group of 0.004% was used.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men and women aged 18-70 (including threshold);
✓. Body mass index between 19-26kg/m2 (including critical value), male weight ≥50kg, female weight ≥45kg;
✓. 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);
✓. Lacrimal secretion test (Schirmer test I) ≥10mm/5min during screening;
✓. Limbus structure was normal under slit-lamp during screening period;
✓. Voluntarily sign informed consent.

Exclusion criteria

✕. Smoking more than 5 cigarettes per day on average;
✕. 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;
✕. those who have a history of drug abuse or have a positive urine test;

What they're measuring

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Trial details

NCT IDNCT07132437

SponsorZhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-05-17

View on ClinicalTrials.gov More Corneal Diseases trials

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Men and women aged 18-70 (including threshold);
✓. Body mass index between 19-26kg/m2 (including critical value), male weight ≥50kg, female weight ≥45kg;
✓. 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);
✓. Lacrimal secretion test (Schirmer test I) ≥10mm/5min during screening;
✓. Limbus structure was normal under slit-lamp during screening period;
✓. Voluntarily sign informed consent.

Exclusion criteria

✕. Smoking more than 5 cigarettes per day on average;
✕. 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;
✕. those who have a history of drug abuse or have a positive urine test;

What they're measuring

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6

Estimate pharmacokinetic parameters

Timeframe: Day 6