NCT06128486已完成不适用
Clinical Evaluation of the Safety and Efficacy of Yung Sheng 55 % Color Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 主要终点
- The effectiveness of corrected visual acuity
研究概览
简要总结
This was a single group, open-label clinical study to assess the safety and efficacy of Yung Sheng 55% Color Contact Lens for vision correction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must sign the informed consent form.
- •The subject must be at least 20 years of age as of the date of evaluation for the study.
- •The subject must have a spherical prescription range between 0 to -12.00 diopters in each eye.
- •The subject must have manifest refraction Snellen visual acuities (VA) less than 0.8 in each naked eye.
- •The subject must have normal eyes, except ametropia.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must appear able and willing to fill the daily card.
排除标准
- •The subjects who need to use ophthalmic medicine for therapy.
- •The subjects who have ocular or systemic allergies or disease that may interfere with contact lens wear.
- •The subjects who have any history of ocular surgery/injury within 8 weeks prior to enrollment.
- •The subjects who have clinically significant tear secretion abnormal.
- •The subjects who enrolled in another contact lens clinical trial within 30 days prior to enrolment.
结局指标
主要结局
The effectiveness of corrected visual acuity
时间窗: 3 Months
The visual acuity after contact lens correction should be more than or equal to 1.0 at the final visit for each subject. The percentage of successful contact lens correction of visual acuity should be more than 90 % among all subjects.
次要结局
- Lens fitting (Lens position)(Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months)
- Lens fitting (Lens movement)(Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months)
- Lens fitting (Lens edge)(Day 1, 1 week, 2 weeks, 1 month, 2 months and 3 months)
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