NCT00639353终止不适用
The Clinical Performance of the Silicone Hydrogel Contact Lens on Low to Moderate Astigmatism in Japan
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 102
- 试验地点
- 10
- 主要终点
- Subject-reported satisfaction for vision
研究概览
简要总结
This study seeks to evaluate the clinical performance of a recently released contact lens designed to correct astigmatism to an established contact lens that has historically been used in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is 18 to 39 years of age. (Parental consent is required for a minor child i.e. under the age of 20.)
- •The subject has signed an informed consent with his/her own judgement for participation in the study.
- •The subject currently is a habitual wearer of spherical or toric daily-wear soft contact lenses, excluding daily disposables, in daily wear bases.
排除标准
- •The subject has any ocular or systemic allergies that interfere with contact lens wear.
- •The subject has dry eye and lacrimal apparatus disease that could interfere with contact lens wear.
- •The subject has any systemic disease or autoimmune disease that interferes with contact lens wear.
- •The subject has corneal edema, neovascularization, corneal staining or other ocular abnormalities (Grade 3 or above) that clinically apparently interfere with contact lens wear.
- •The subject has any anterior segment eye disease (palpebral abnormalities, corneal hypesthesia, corneal epithelial defect, bulbar conjunctival hyperemia, etc.) that clinically apparently interferes with contact lens wear.
- •The subject has a history of solution reactions to the chemical cleaner/disinfectant to be used in this study, as far as known to the subject.
- •The subject has ocular infection.
- •The subject has ocular inflammation (including acute/subacute anterior segment inflammations and uveitis).
- •The subject has corneal distortion resulting from previous experience of hard contact lens wear.
- •The subject has infectious disease (pneumonia, tuberculosis, etc.) or immunosuppressive disease (HIV positive etc.), as far as known to the subject.
- •The subject has diabetes, as far as known to the subject.
- •The subject is pregnant or in the lactation period, as far as known to the subject.
- •The subject uses any eye remedies (excluding artificial tear substitutes or hyaluronic acid drops for reducing dryness while wearing contact lenses).
- •The subject had any ocular trauma or surgery within 8 weeks prior to participation in the study.
- •The subject is a wearer of hard contact lenses (including rigid gas permeable).
- •The subject is exposed to a dry environment on a constant basis.
- •The subject is exposed to a living environment where dust, chemicals, etc. can easily enter the eye.
- •The subject is unable to follow the principal investigator's instructions.
- •The subject is unable to follow lens hygiene procedures necessary for contact lens wear.
结局指标
主要结局
Subject-reported satisfaction for vision
时间窗: After 2 weeks of lens wear
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
Subject-reported satisfaction for comfort.
时间窗: After 2 weeks of lens wear
Scale of 0 to 100, were 0=extremely poor and 100=Excellent
次要结局
- Subject preference for lens type.(After 2 weeks of lens wear.)
研究者
研究点 (10)
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