Clinical Evaluation of CooperVision MyDay Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Lens Lag
研究概览
简要总结
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).
详细描述
This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.
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
- Single (Participant)
盲法说明
Each subject will be masked as to which lens is worn on each eye.
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
- •A person is eligible for inclusion in the study if he/she:
- •Is Japanese
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and understood the informed consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- •Currently wears soft contact lenses.
- •Has clear corneas and no active ocular disease.
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
结局指标
主要结局
Lens Lag
时间窗: 3hrs
Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)
Vertical Lens Centration
时间窗: 3hrs
Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)
Corneal Coverage
时间窗: 3hrs
Does lens cover the cornea: (Yes, No)
Investigator Fit Preference
时间窗: 3hrs
Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)
Lens Movement
时间窗: 3hrs
Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)
Horizontal Lens Centration
时间窗: 3hrs
Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)
Overall Fitting Performance
时间窗: 3hrs
Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)
次要结局
- Dryness(3 hours)
- Comfort(3 hours)
- Subjective Lens Preference(3 hours)
- Stinging/Burning(3 hours)
- Edge/Lens Awareness(3 hours)