Clinical Validation of Etafilcon A With Print and PVP Contact Lenses for Dark Eyes and Light Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 30
- 主要终点
- Lens Fit Acceptance
研究概览
简要总结
This study will serve to evaluate and compare the performance of two new lenses to a marketed lens.
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 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Healthy, female adult, at least 18 years of age, and no more than 34 years of age
- •The subjects must be female, light eye Caucasian, Non-Hispanic, habitual soft contact lens wearer (both eyes) with light or dark eyes
- •Must have rated the Concept Statement positively (i.e., a rating of 4 or 5).
- •Optimal vertexed spherical equivalent distance correction must be between -1.00 and -4.00 diopters (D)
- •Any cylinder power must be: <=0.75D
- •Visual acuity must be best correctable to 20/25 or better for each eye
- •Must have normal eyes (no ocular medications or ocular infection of any type)
- •Must read and sign the Statement of Informed Consent
- •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, autoimmune disease, or use of medication which might interfere with contact lens wear
- •Clinically significant (grade 3 or worse) corneal edema, corneal neovascularization, 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 (colorblindness) - 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.
- •Subject presents with one dark iris color and one light iris color.
- •Subject has heterochromia iridis (a difference in color between parts of one iris).
- •The subject must not be an employee or family member of the clinical study site.
研究组 & 干预措施
EALE/1DM
etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A control lens (1DM) (Device)
EALE/1DM
etafilcon A with PVP for light eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A with print and PVP for light eyes (EALE) (Device)
1DM/EALE
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A control lens (1DM) (Device)
1DM/EALE
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for light eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A with print and PVP for light eyes (EALE) (Device)
EADE/1DM
etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A control lens (1DM) (Device)
EADE/1DM
etafilcon A with PVP for dark eyes worn during the first period of 7-9 days then etafilcon A control lens worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A with print and PVP for dark eyes (EADE) (Device)
1DM/EADE
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A control lens (1DM) (Device)
1DM/EADE
etafilcon A control lens worn during the first period of 7-9 days then etafilcon A with PVP for dark eyes worn during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A with print and PVP for dark eyes (EADE) (Device)
结局指标
主要结局
Lens Fit Acceptance
时间窗: Dispensing
The overall lens fit was evaluated by the Investigators for each eye whether it was acceptable (yes/no).
Monocular Visual Acuity
时间窗: Dispensing
Monocular distance Snellen visual acuity (VA) scores were coverted to the algorithm of the minimal angle of resolution (LogMAR) scale based on the following formula: LogMAR = Log10 (VA/20) - a\*VAR, where Log10 = base 10 logarithm, VA = the Snellen denominator score, a = LogMAR stepsize coefficient and VAR = letter gained or missing in addition to the Snellen denominator score.
Corneal Staining of Grade 3 or 4
时间窗: After 7-9 days of lens wear
Corneal staining was graded using a 5-point scale; 0=None(no staining), 1=Trace, 2=Mild, 3=Moderate, and 4=Severe. Only those eyes with corneal staining grade \>= 3 were reported.
次要结局
未报告次要终点