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

Overview

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.

Full Title of Study: “A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of ZKY001 Eye Drops in Patients With Corneal Epithelial Defects After Corneal Endothelial Transplantation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: October 31, 2020

Detailed Description

This study is an exploratory phase II clinical study with no sample size estimation.According to the results of the preliminary animal experiments and phase I clinical trials, 2 concentrations (0.002% and 0.004%ZKY001eye drops) were selected as the experimental group, and 1 placebo control group was selected, with 35 subjects in each group and a total of 105 subjects.Each subject will drop the study drug into the test eye (the surgical eye is taken as the test eye) according to the randomly assigned drug number.

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

Arms, Groups and Cohorts

  • Experimental: 0.002% ZKY001 eye drops
    • Experimental group A: 35 subjects .0.002% ZKY001 eye drops . 4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
  • Experimental: 0.004% ZKY001 eye drops
    • Experimental group B: 35 subjects .0.004% ZKY001 eye drops . 4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).
  • Placebo Comparator: The placebo
    • Placebo group C: ZKY001 simulated eye drops .4 times a day,1 drop every time, continuously administered for 14±2 days ZKY001 simulated eye drops will be directly dripped into the test eye (the surgical eye was taken as the test eye).

Clinical Trial Outcome Measures

Primary Measures

  • The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
    • Time Frame: Day 3, 8:00 am±1hour
    • Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1(the first day after surgery,baseline),Day3 (the third day after surgery).After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Improvement in epithelial defect area = defect area on baseline – defect area on Day3

Secondary Measures

  • The subject’s symptoms and signs will be evaluated on the General Arbitroid
    • Time Frame: Day 3, Day6 、Day15 8:00 am±1hour
    • Subjects’ symptoms and signs were evaluated on the general symptom and signs scale at Day1 before fluorescein staining of the cornea. The mean change of the total score of symptoms and signs on Day 3、Day6 、Day15 after the operation compared with the baseline
  • The improvement rate of corneal epithelial defect area on Day 3 postoperation after surgery compared with that at baseline (Day1 postoperation ) will be calculated by the grid method
    • Time Frame: Day 3, 8:00 am±1hour
    • Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1(the first day after surgery,baseline),Day3 (the third day after surgery).After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Improvement rate of corneal epithelial defect area=( defect area at baseline – defect area at Day3)/defect area at baseline ✖100%
  • The change of corneal epithelial defect area on Day 2、Day4、Day5 compared with that on baseline(Day 1) will be calculated by the grid method
    • Time Frame: Day 2、Day4、Day5 8:00 am±1hour
    • Subjects will undergo fluorescein staining of the cornea, slit-lamp examination and photography (8:00 ±1h) before first administration on Day1,Day 2、Day4、Day5.After slit-lamp photography was scanned by the scanner, image pro plus software was used to scale the photo to the same size as the test eye, and then the grid method was used to calculate the area of the corneal defect in the photo. Day2 Improvement in epithelial defect area = defect area on baseline – defect area on Day2 Day4Improvement in epithelial defect area = defect area on baseline – defect area on Day4 Day5 Improvement in epithelial defect area = defect area on baseline – defect area on Day5

Participating in This Clinical Trial

Inclusion Criteria

1. age 18-80, regardless of gender;

2. patients who have undergone DSAEK or DMEK and need to remove corneal epithelium;

3. Schirmer test I ≥10mm/5min;

4. normal corneal limbus structure under slit lamp during screening period;

5. sign the informed consent.

Exclusion Criteria

1. intraocular pressure > 21mmHg or baseline intraocular pressure > 35mmHg during screening period;

2. fasting blood glucose > 9.0mmol/L during screening period;

3. postoperative complications occurred, such as dislocation of the implant and high intraocular pressure caused by air bubbles in the anterior chamber;

4. suffered from eye infection, optic neuritis, pigment membrane inflammation, or fundus, macular lesions that affect vision, glaucoma;

5. serious cardiovascular history (congestive heart failure, uncontrolled hypertension, unstable coronary heart disease or myocardial infarction or severe arrhythmia, etc.);

6. severe hepatic and renal insufficiency, alanine aminotransferase (ALT), alanine aminotransferase (AST) ≥ 2 times the normal upper limit, blood creatinine (Cr) ≥ 1.5 times the normal upper limit;

7. those who wear contact lenses within 3 days before screening;

8. screening drugs that have used corneal repair effect within the first 3 days;

9. have received corneal refractive surgery or keratoplasty;

10. have received internal eye surgery within 3 months before screening or need to undergo internal eye surgery during the study period;

11. have participated in other clinical trials or are participating in other clinical trials within 3 months prior to screening;

12. suffering from central nervous system disease and/or mental state inability to cooperate;

13. women in pregnancy, lactation or childbearing age do not take effective contraceptive measures;

14. allergy to the test product and basic drugs;

15. patients who are not considered appropriate to participate in this study, including those who are unable or unwilling to comply with the protocol requirements.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiuli Zhao, PHD, Study Director, Beijing Tongren Hospital
  • Overall Contact(s)
    • Xiuli Zhao, PHD, 010-58268486, xiulizhao@medmail.com.cn

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