Study of ACUVUE® ADVANCE® PLUS Contact Lenses.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Visual Acuity (VA)
研究概览
简要总结
The purpose of this study is to compare ACUVUE® ADVANCE® Plus contact lenses made prior to process qualification (prePQ) against the ACUVUE® ADVANCE® Plus lenses made after the process qualification (postPQ).
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 and willing to wear the study lenses on a daily wear basis for the duration of the study (minimum of 6 hours per day).
- •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 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
Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second.
干预措施: Acuvue Advance Plus prePQ (Device)
Acuvue Advance Plus prePQ/Acuvue Advance Plus postPQ
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification will be worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after process qualification will be worn second.
干预措施: Acuvue Advance Plus postPQ (Device)
Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second.
干预措施: Acuvue Advance Plus prePQ (Device)
Acuvue Advance Plus postPQ/Acuvue Advance Plus prePQ
Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to process qualification worn first and Acuvue Advance Plus silicone hydrogel contact lens manufactured after process qualification worn second.
干预措施: Acuvue Advance Plus postPQ (Device)
结局指标
主要结局
Visual Acuity (VA)
时间窗: 6-8 days after lens wear
Snellen VA was measured to the nearest letter then converted to the logMAR scale for the analysis. Values \< 0 imply a clinically positive result; while values \> 0 infer a clinically negative result.
次要结局
- Limbal Redness(6-8 days after lens wear)
- Bulbar Redness(6-8 days after lens wear)
- Corneal Staining(6-8 days after lens wear)