NCT06527586已完成不适用
A Study to Evaluate the Safety and Efficacy of Eye Secret UV Aspheric Silicone Soft (Hydrophilic) 1Day Color Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 3
- 主要终点
- The effectiveness of corrected visual acuity
研究概览
简要总结
This was a prospective, randomized, open label, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Color Contact Lens for vision correction.
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
- None
入排标准
- 年龄范围
- 20 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 20 to
- •Subject with -1.00 to -10.00 D myopia, less than 1.00 D astigmatism.
- •Subjects must be correctable through spherocylindrical refraction and with soft contact lenses to 0 Log MAR (distance) or better in each eye.
- •Willing to comply with all study procedures and be available for the study duration.
- •Provide signed and dated informed consent form.
排除标准
- •Subjects have a history of allergies that contraindicate contact lens wear.
- •Subjects have other active ocular or systemic diseases such as, but not limited to anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or diabetes.
- •Subjects have medications that would contraindicate contact lens wear.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 months.
- •Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Any active participation in any contact lens or lens care product clinical trial within seven days prior to this study.
- •The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
- •Subject has a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
- •Subject has a history of papillary conjunctivitis that has interfered with contact lens wear.
- •Subject has a history of herpetic keratitis retinal detachment or irregular cornea.
- •Subject has a history of recurrent eye or eyelid infections, adverse effects associated with your contact lens wear, intolerance or unusual response to your contact lens wear.
- •The subject has over grade II corneal and conjunctival staining (Oxford scheme) if who has a history of dry eye.
- •Subject had any corneal surgery (e.g., refractive surgery).
结局指标
主要结局
The effectiveness of corrected visual acuity
时间窗: 3 Months
The primary effectiveness endpoint of the study was the comparison of the mean change in logMAR visual acuity (VA) of the subject's worse eye, from baseline (Day 1) to the final visit (3-month), between the groups wearing test lenses and control lenses.
次要结局
- Effectiveness of corrected visual acuity(1 Week)
研究者
研究点 (3)
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