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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-29

Study Completion Date

2022-05-17

Brief Summary

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One dose group of 0.004% was used.

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Detailed Description

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

Conditions

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Corneal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A dose group of 0.004% was used

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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0.004% ZKY001 eye drops

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

Group Type EXPERIMENTAL

ZKY001 EYE DROPS

Intervention Type DRUG

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.

Interventions

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ZKY001 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.

Intervention Type DRUG

Other Intervention Names

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Germinal peptide eye drops

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No