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
Overview
- Phase
- Phase 2
- Intervention
- ZKY001 simulated eye drops
- Conditions
- Corneal Defect
- Sponsor
- Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
- Enrollment
- 105
- Locations
- 1
- Primary Endpoint
- The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age 18-80, regardless of gender;
- •patients who have undergone DSAEK or DMEK and need to remove corneal epithelium;
- •Schirmer test I ≥10mm/5min;
- •normal corneal limbus structure under slit lamp during screening period;
- •sign the informed consent.
Exclusion Criteria
- •intraocular pressure \> 21mmHg or baseline intraocular pressure \> 35mmHg during screening period;
- •fasting blood glucose \> 9.0mmol/L during screening period;
- •postoperative complications occurred, such as dislocation of the implant and high intraocular pressure caused by air bubbles in the anterior chamber;
- •suffered from eye infection, optic neuritis, pigment membrane inflammation, or fundus, macular lesions that affect vision, glaucoma;
- •serious cardiovascular history (congestive heart failure, uncontrolled hypertension, unstable coronary heart disease or myocardial infarction or severe arrhythmia, etc.);
- •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;
- •those who wear contact lenses within 3 days before screening;
- •screening drugs that have used corneal repair effect within the first 3 days;
- •have received corneal refractive surgery or keratoplasty;
- •have received internal eye surgery within 3 months before screening or need to undergo internal eye surgery during the study period;
Arms & Interventions
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).
Intervention: ZKY001 simulated eye drops
Outcomes
Primary Outcomes
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 Outcomes
- Scoring with D6 and D15 corneal fluorescein staining(Day6 、Day15 8:00 am±1hour)
- The incidence of reexfoliation of corneal epithelium was observed(Day 3, Day4，Day5，Day6，Day15±2 8:00 am±1hour)
- The subject's symptoms and signs will be evaluated on the General Arbitroid(Day 3, Day6 、Day15 8:00 am±1hour)
- 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(Day 3, 8:00 am±1hour)
- 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(Day 2、Day4、Day5 8:00 am±1hour)