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

NCT ID: NCT04228926

Last Updated: 2021-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-24
• Study Completion Date: 2021-12-31

Brief 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.

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.

Conditions

Corneal Defect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

ZKY001 eye drops 0.3g:0.006mg

Intervention Type: DRUG

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

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).

Group Type: EXPERIMENTAL

ZKY001 eye drops 0.3g:0.012mg

Intervention Type: DRUG

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

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).

Group Type: PLACEBO_COMPARATOR

ZKY001 simulated eye drops

Intervention Type: DRUG

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

Interventions

ZKY001 eye drops 0.3g:0.006mg

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

Intervention Type: 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

Intervention Type: DRUG

ZKY001 simulated eye drops

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

Intervention Type: DRUG

Other Intervention Names

shengfatai-eye drops; the Germinal Peptide eye drops; shengfatai-eye drops; the Germinal Peptide eye drops; the placebo

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiuli Zhao, PHD

Role: STUDY_DIRECTOR

Beijing Tongren Hospital

Locations

Eye ＆ Ent Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiuli Zhao, PHD

Role: CONTACT

xiulizhao@medmail.com.cn

010-58268486 ext. 8008

Feng Wu, PHD

Role: CONTACT

bjtrec@126.com

010-58268486 ext. 8008

Facility Contacts

Yan Wang, PHD

Role: primary

021-64377134

Other Identifiers

ZK-SFT-2019

Identifier Type: -

Identifier Source: org_study_id