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A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops

NCT06209203 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-15

No results posted yet for this study

Summary

A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.

Conditions

  • Corneal Epithelium Defect

Interventions

DRUG

lowe-dose ZKY001 eye drops

eye drops

DRUG

Medium-dose ZKY001 eye drops

eye drops

DRUG

placebo

eye drops

Sponsors & Collaborators

  • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xingtao Zhou · Eye & ENT Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-03
Primary Completion
2022-11-08
Completion
2022-11-08

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT06209203 on ClinicalTrials.gov