The Clinical Evaluation of Two Daily Disposable Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Distance Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •They are of legal age (18 years) and capacity to volunteer.
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They would be expected to attain at least 6.9 (20/30) in each eye with the study lenses.
- •They are able to wear contact lenses which have a back vertex power of -1.00 to -6.00DS.
- •They have a maximum of 1.00D of refractive astigmatism (i.e. < 1.00 DC).
- •They have worn soft contact lenses within six months of starting the study.
排除标准
- •They have an ocular disorder which would normally contra-indicate contact lens wear.
- •They have a systemic disorder which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or has keratoconus.
- •They are pregnant or lactating.
- •They have grade 2 or greater of any of the following ocular surface signs: corneal edema, corneal vascularization, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.
- •They have any infectious disease (e.g., hepatitis) or any immunosuppressive disease (e.g., HIV).
- •They have diabetes.
- •They are currently taking part in any other clinical study or research.
研究组 & 干预措施
etafilcon A/omafilcon A
Period 1: etafilcon A, Period 2: omafilcon A
干预措施: etafilcon A (Device)
etafilcon A/omafilcon A
Period 1: etafilcon A, Period 2: omafilcon A
干预措施: omafilcon A (Device)
omafilcon A/etafilcon A
Period 1: omafilcon A, Period 2: etafilcon A
干预措施: etafilcon A (Device)
omafilcon A/etafilcon A
Period 1: omafilcon A, Period 2: etafilcon A
干预措施: omafilcon A (Device)
omafilcon A/omafilcon A
Period 1: omafilcon A, Period 2: omafilcon A
干预措施: omafilcon A (Device)
etafilcon A/etafilcon A
Period 1: etafilcon A, Period 2: etafilcon A
干预措施: etafilcon A (Device)
结局指标
主要结局
Distance Visual Acuity
时间窗: 1 week
logarithm of the minimum angle of resolution (logMar) ideal is 0.0 and represents 20/20 Snellen acuity. logMar values \> 0.00 indicate vision poorer than the ideal and values \<0.00 indicate vision greater than the ideal.
次要结局
- Lens Comfort(1 week)