Dispensing Evaluation of Lens Comfort and Subjective Vision of an Etafilcon A With Print and PVP Lens for Dark Eyes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 6
- 主要终点
- Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
研究概览
简要总结
To evaluate and compare the performance of a new contact lens to a marketed contact 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
- •The subject must be a healthy adult at least 18 years of age and no more than 34 years of age.
- •The subjects must be female, dark eye Caucasian, Non-Hispanic habitual soft contact lens wearer (both eyes).
- •The subject rated the Concept Statement positively (i.e., a rating of 4 or 5). If not the subject is not eligible to participate.
- •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 -4.00D.
- •Any cylinder power must be:<=0.75D.
- •The subject must have visual acuity best correctable to 20/25 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, 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 (color blindness) - to the best of the subject's knowledge.
- •Pregnancy or lactation.
- •Diabetes.
- •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 is an employee or family member of the clinical study site.
研究组 & 干预措施
EAPVPDE/EADE
etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A with print and PVP for dark eyes (EAPVPDE) (Device)
EAPVPDE/EADE
etafilcon A with embedded print and PVP lens for dark eyes worn daily during the first period of 7-9 days, then etafilcon A control lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A control lens (EADE) (Device)
EADE/EAPVPDE
etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A with print and PVP for dark eyes (EAPVPDE) (Device)
EADE/EAPVPDE
etafilcon A control lens worn daily during the first period of 7-9 days, then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days, with 1-3 days of wash-out time between the 2 periods.
干预措施: etafilcon A control lens (EADE) (Device)
结局指标
主要结局
Subject Reported Overall Quality of Lens Vision Using the Contact Lens User Evaluation (CLUE) Questionnaire
时间窗: After 7 to 9 days of lens wear
The overall quality of lens vision was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range from 0-120.
Subject Reported Overall Lens Handling Using the Contact Lens User Evaluation (CLUE) Questionnaire
时间窗: After 7 to 9 days of lens wear
The overall lens handling was assessed using the CLUE questionnaire after 7-9 days of follow-up. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Subject Reported Overall Lens Comfort Using the Contact Lens User Evaluation (CLUE) Questionnaire
时间窗: After 7 to 9 days of lens wear
The overall lens comfort was assessed using the CLUE questionnaire after 7-9 days of follow-up.The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
次要结局
未报告次要终点