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
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
- •have participated in other clinical trials or are participating in other clinical trials within 3 months prior to screening;
- •suffering from central nervous system disease and/or mental state inability to cooperate;
- •women in pregnancy, lactation or childbearing age do not take effective contraceptive measures;
- •allergy to the test product and basic drugs;
- •patients who are not considered appropriate to participate in this study, including those who are unable or unwilling to comply with the protocol requirements.
研究组 & 干预措施
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).
干预措施: ZKY001 simulated eye drops (Drug)
结局指标
主要结局
The change of corneal epithelial defect area on Day 3 compared with that on baseline will be calculated by the grid method
时间窗: 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
次要结局
- 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)