A Multi-site Dispensing Evaluation Comparing a New Galyfilcon A Prototype Lens With a Marketed Galyfilcon A Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 9
- 主要终点
- Lens Front Surface Deposits at Day 7
研究概览
简要总结
The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be at least 18 years of age and no more than 39 years of age.
- •The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study.
- •The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D.
- •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 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 4) 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.
- •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.
研究组 & 干预措施
galyfilcon A prototype/marketed galyfilcon A
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.
干预措施: galyfilcon A prototype lens (Device)
galyfilcon A prototype/marketed galyfilcon A
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.
干预措施: marketed galyfilcon A lens (Device)
marketed galyfilcon A/galyfilcon A prototype
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.
干预措施: galyfilcon A prototype lens (Device)
marketed galyfilcon A/galyfilcon A prototype
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.
干预措施: marketed galyfilcon A lens (Device)
结局指标
主要结局
Lens Front Surface Deposits at Day 7
时间窗: Evaluated at Day 7
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
Lens Front Surface Deposits at Day 14
时间窗: Evaluated at Day 14
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
次要结局
- Subject Reported Overall Lens Comfort at Day 7(Evaluated at Day 7)
- Subject Reported Overall Lens Comfort at Day 14(Evaluated at Day 14)