A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase II Clinical Trial to Evaluate the Efficacy and Safety of ZKY001 Eye Drops in Patients with Corneal Epithelial Defects After TPRK
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- healing time
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. A total of 120 subjects were randomly assigned to two experimental groups (lowe-dose ZKY001 eye drops group,Medium-dose ZKY001 eye drops group) and a placebo control group, with 40 subjects in each group.
详细描述
Study cycle: 7 days screening period (d-7-D-1), 7 days treatment period (D0-D6), and the end of the study on D7.
Statistical analysis was performed using SAS9.4 or above software. All statistical tests were two-sided, and P less than or equal to 0.05 was considered statistically significant for the difference being tested unless specified.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-40 years old, regardless of gender;
- •Plan TPRK for myopia and/or myopic astigmatism, meet the indications for TPRK, and set the ablation diameter of the optical zone at 6.0-6.5 mm;
- •Schirmer test I ≥10mm/5min;
排除标准
- •prior corneal refractive surgery or keratoplasty;
- •Contraindications to TPRK surgery, including severe ocular surface disease that may affect the corneal epithelium, active ocular inflammation, moderate to severe dry eye, keratoconus or other types of corneal ectasia, thin corneas, severe lesions of ocular appendages (such as eyelid defects, deformations, etc.), glaucoma, cataract that affects vision, History of systemic immune diseases (systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, etc.);
- •incomplete eyelid closure;
- •corneal degeneration, corneal stroma or endothelial damage or malnutrition;
研究组 & 干预措施
lowe-dose ZKY001 eye drops
The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6
干预措施: lowe-dose ZKY001 eye drops (Drug)
Medium-dose ZKY001 eye drops
The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6
干预措施: Medium-dose ZKY001 eye drops (Drug)
placebo
The drug was given once immediately after surgery on D0, and 1 drop was given 4 times a day from D0 to D6
干预措施: placebo (Drug)
结局指标
主要结局
healing time
时间窗: seven days
Corneal epithelial healing time
次要结局
- number of healing(seven days)