NCT01875471已完成不适用
Clinical Evaluation 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
- 279
- 试验地点
- 11
- 主要终点
- Subjective Ease of Lens Removal
研究概览
简要总结
The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add.
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
- •The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits.
- •The subject must be a current successful spherical soft contact lens wearer in both eyes.
- •The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol.
- •The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye.
- •The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes.
- •The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye.
- •The subject must require a visual correction in both eyes (no monofit or monovision allowed).
排除标准
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Currently pregnant or lactating (subject who become pregnant during the study will be discontinued).
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
- •Evidence of lid abnormality or infection (including blepharitis/meibomitis)
- •Conjunctival abnormality or infection.
- •Any active ocular disease.
- •Employee or family member of the staff of the investigational site.
研究组 & 干预措施
delefilcon A
Active Comparator
Spherical daily disposable soft contact lens
干预措施: delefilcon A (Device)
narafilcon A
Experimental
Spherical daily disposable soft contact lens Class 1 UV blocking
干预措施: narafilcon A (Device)
结局指标
主要结局
Subjective Ease of Lens Removal
时间窗: Day 7
After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).
次要结局
未报告次要终点
研究者
研究点 (11)
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