Dispensing Evaluation of Printed Etafilcon A With Polyvinylpyrrolidone (PVP) Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 6
- 主要终点
- Lens Fit Acceptance
研究概览
简要总结
The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subject must be at least 18 years of age and less than 40 years of age.
- •The subject must be a light eye Caucasian female habitual soft contact lens wearer.
- •The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible.
- •The subject must have no known ocular or systemic allergies that might interfere with contact lens wear.
- •The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear.
- •The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
- •Any cylinder power must be ≤ -0.75D.
- •The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- •The subject must have normal eyes (no ocular medications or ocular infection of any type).
- •The subject must read and sign the Statement of Informed Consent.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
排除标准
- •Ocular or systemic allergies or disease which might interfere with contact lens wear.
- •Systemic disease or use of medication which might interfere with contact lens wear.
- •Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, corneal staining, 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.
- •Any color deficiencies - to the best of the subject's knowledge.
- •Pregnancy or lactation.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- •Habitual contact lens type is toric, multifocal, or is worn as extended wear.
研究组 & 干预措施
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (A) (Device)
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (B) (Device)
etafilcon A (A)/etafilcon A (B)/etafilcon A (C)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (C) (Device)
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (A) (Device)
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (B) (Device)
etafilcon A (A)/etafilcon A (C)/etafilcon A (B)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (C) (Device)
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (A) (Device)
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (B) (Device)
etafilcon A (C)/etafilcon A (A)/etafilcon A (B)
Printed etafilcon A Lens with PVP (A) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (B) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (C) (Device)
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)
Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (A) (Device)
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)
Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (B) (Device)
etafilcon A (B)/etafilcon A (C)/etafilcon A (A)
Printed etafilcon A Lens with PVP (B) worn first, then printed etafilcon A Lens with PVP (C) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (C) (Device)
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (B) (Device)
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (C) (Device)
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (A) (Device)
etafilcon A (C)/etafilcon A (B)/etafilcon A (A)
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (B) worn second, then printed etafilcon A Lens with PVP (A) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (A) (Device)
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (B) (Device)
etafilcon A (B)/etafilcon A (A)/etafilcon A (C)
Printed etafilcon A Lens with PVP (C) worn first, then printed etafilcon A Lens with PVP (A) worn second, then printed etafilcon A Lens with PVP (C) worn the last. Each period consisted of approximately one week of daily lens wear.
干预措施: etafilcon A (C) (Device)
结局指标
主要结局
Lens Fit Acceptance
时间窗: 10-15 minutes post lens fit
Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.
次要结局
- Binocular Snellen Visual Acuity (VA)(10-15 minutes post lens fit)
- Corneal Staining(After 6-9 days of lens wear)