NCT00775021已完成不适用
A Clinical Comparison of Two Daily Disposable Contact Lenses.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Overall Comfort
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years to 45 years
- •Current daily soft contact lens as habitual optical correction:
- •Refraction:
- •Best sphere (corrected for back vertex distance) -1.00 to -6.00D
- •Cylinder 0.00 to - 0.75D
- •Best spectacle corrected visual acuity of 6/9 or better in each eye
- •Willingness to adhere to the instructions set in the clinical protocol
- •Signature of the subject on the informed consent form
排除标准
- •Systemic or ocular allergies which might interfere with contact lens wear
- •Systemic disease which might interfere with contact lens wear
- •Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
- •Use of medication which might interfere with contact lens wear
- •Active ocular infection
- •Use of ocular medication
- •Significant ocular anomaly
- •Presence of two or more corneal scars in either eye
- •Pregnancy or lactation
- •Any medical condition that might be prejudicial to the study
- •Participated in any other clinical studies in the past month
- •Currently wears monovision
研究组 & 干预措施
etafilcon A/nelfilcon A
Active Comparator
etafilcon A contact lens worn first and nelfilcon A contact lens worn second
干预措施: etafilcon A (Device)
etafilcon A/nelfilcon A
Active Comparator
etafilcon A contact lens worn first and nelfilcon A contact lens worn second
干预措施: nelfilcon A (Device)
nelfilcon A/etafilcon A
Active Comparator
nelfilcon A contact lens worn first and etafilcon A contact lens second.
干预措施: etafilcon A (Device)
nelfilcon A/etafilcon A
Active Comparator
nelfilcon A contact lens worn first and etafilcon A contact lens second.
干预措施: nelfilcon A (Device)
结局指标
主要结局
Overall Comfort
时间窗: 1 week
Subjects rated study contact lens for overall comfort using the following scale: 5=excellent, 4=very good, 3=good, 2=fair, 1=poor.
次要结局
- Inferior Region Corneal Staining(1 week)
- End of the Day Comfort(1 week)
- Initial Comfort(1 Week)
- Overall Lens Handling(1 week)
研究者
研究点 (2)
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