Pilot Dispensing Evaluation of a Plus Power Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Visual Acuity One Week After Lens Wear
研究概览
简要总结
The purpose of this study is to compare the performance of the ACUVUE® ADVANCE® Plus lenses against ACUVUE® ADVANCE® lenses in the plus power parameters.
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 45 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 45 years of age.
- •The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study (defined as a minimum of 6 hours with a minimum of at least 1 month's wear prior to the study).
- •The subject's optimal verified spherical equivalent distance correction must be between +1.00 and + 6.00D.
- •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 the 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, bifocal, in monovision contact lens wear, or is worn as extended wear.
- •Need any near correction.
研究组 & 干预措施
Acuvue Advance Plus/ Acuvue Advance
Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
干预措施: Acuvue Advance Plus (Device)
Acuvue Advance Plus/ Acuvue Advance
Acuvue Advance Plus contact lenses worn first period and Acuvue Advance contact lenses worn second.
干预措施: Acuvue Advance (Device)
Acuvue Advance/Acuvue Advance Plus
Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
干预措施: Acuvue Advance Plus (Device)
Acuvue Advance/Acuvue Advance Plus
Acuvue Advance contact lenses worn first period and Acuvue Advance Plus contact lenses worn second.
干预措施: Acuvue Advance (Device)
结局指标
主要结局
Visual Acuity One Week After Lens Wear
时间窗: 1 week
Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.
Visual Acuity at Time of Initial Fit
时间窗: After 10-15 minutes of lens wear
Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.
次要结局
- Contact Lens Comfort Using Contact Lens User Experience (CLUE)(1 week)
- Subject Reported Vision Using Contact Lens User Experience (CLUE).(1 week)
- Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)(Baseline)
- Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)(Baseline)