Clinical trial NCT04228926: Evaluating the Efficacy and Safety of ZKY001 Eye Drops in the Treatment of Corneal Epithelial Defects
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Corneal Defect
Lead sponsor: Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
timeFrame: Day 3, 8:00 am±1hour
Secondary outcomes:
measure: The subject's symptoms and signs will be evaluated on the General Arbitroid
timeFrame: Day 3, Day6 、Day15 8:00 am±1hour
measure: Scoring with D6 and D15 corneal fluorescein staining
timeFrame: Day6 、Day15 8:00 am±1hour
measure: 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
timeFrame: Day 3, 8:00 am±1hour
measure: 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
timeFrame: Day 2、Day4、Day5 8:00 am±1hour
measure: The incidence of reexfoliation of corneal epithelium was observed
timeFrame: Day 3, Day4，Day5，Day6，Day15±2 8:00 am±1hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eye ＆ Ent Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Beijing Tongren Hospital
name: Xiuli Zhao, PHD
role: STUDY_DIRECTOR
References: