Clinical Trial Protocol for Safety and Efficacy of Soft Contact Lens (Model: Spherical Lens)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The ratio of corrected visual acuity of left and right eyes is ≥5.0
研究概览
简要总结
This project is a multi-center, randomized, parallel-controlled, non-inferior clinical trial of soft contact lenses.
详细描述
The test product is the Soft Contact Lens (model: Spherical Lens), and the control product is a commercially available soft contact lens (model: SiHy Daily). The number of enrolled subjects is 148, and clinical observation is performed for 3 months.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female with age of 18 to 45
- •Spherical power: -0.25 to -10.00D
- •Cylinder power ≤0.75D and Sph.P:Cyl.P≥3:1, or 1.00D≤ cylinder power ≤1.50D and Sph.P:Cyl.P ≥4:1;
- •Both eyes are ametropia, and there is no case where the investigator believes that the soft contact lens cannot be worn;
- •: The case of wearing a soft contact lens as referred to in this trial is: i) No eyelid abnormalities or infections; ii) No clinically significant slit lamp findings iii) No other active eye diseases.
- •BCVA of the left and right eye subjective refraction is greater than or equal to 5.0.
排除标准
- •Need to use therapeutic ophthalmic drugs, including antibiotics, hormones and compound ophthalmic drugs containing hormones
- •Dry eye syndrome
- •Any systemic disease contraindications to contact lenses or disease medications can affect the wearing of contact lenses
- •Wearing a hard contact lens in the past 6 weeks
- •Tear film break-up time is less than or equal to 5s
- •Allergic to contact lenses and/or contact lenses
- •Keratoconus or other irregular corneal patients
- •Soft hydrophilic contact lens wearers are affected by long-term special conditions such as dryness, severe dust or volatile chemicals
- •Pregnant, lactating or plan to be pregnant
- •Only one eye meets the requirements for enrollment
- •Participating in other clinical trials or less than ten days after the end of a soft contact lens clinical trial
- •Less than three months after the end of a drug clinical trial
- •Determined by the investigator that could not be enrolled
结局指标
主要结局
The ratio of corrected visual acuity of left and right eyes is ≥5.0
时间窗: 1 week
The standard logarithmic visual acuity chart consistent with the guiding principle is adopted in this scheme. - Success criteria: If the lower limit of 95% CI of the evaluated rate of corrected for visual acuity for both eyes ≥ 5.0 at 1 week visit is ≥-10%, the primary endpoint of the two groups is non-inferior.
The occurrence of adverse events
时间窗: 3 month
Compare the number of adverse events and serious adverse events, the number of cases and the incidence rate; list the number and cases of adverse events; describe the adverse events that are related to the investigational products.
次要结局
- BCVA (spectacles) and BCVA (CL)(1 week, 1 month, 3 months)