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Phase I Clinical Study of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defect | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT07132437•Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

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;

Locations (1)

Zhiqiang Pan

Beijing, China

Key Dates

Start Date

December 29, 2021

Primary Completion Date

May 17, 2022

Completion Date

May 17, 2022

Last Updated

August 20, 2025

Enrollment

ACTUAL participants

Conditions

Corneal Diseases

Interventions

ZKY001 EYE DROPS

DRUG

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RECRUITINGEARLY_PHASE1

Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Validation of the Use of Terahertz Scanning System on Corneal Scars and Corneal Edema

Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis

Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye

Functional Antigen Matching in Corneal Transplantation

Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk