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Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects

NCT04228926 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-09-17

No results posted yet for this study

Summary

The subjects of this study were patients who underwent corneal endothelial transplantation,who were randomly divided into 3 groups, 2 groups (0.002% and 0.004% ZKY001 eye drops) and 1 placebo control group.

Conditions

  • Corneal Defect

Interventions

DRUG

ZKY001 eye drops 0.3g:0.006mg

ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation

DRUG

ZKY001 eye drops 0.3g:0.012mg

ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation

DRUG

ZKY001 simulated eye drops

ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiuli Zhao, PHD · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-24
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04228926 on ClinicalTrials.gov