Dispensing Evaluation of a Prototype Contact Lens and a Marketed Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Visual Acuity Monocular
研究概览
简要总结
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already 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 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.
- •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 lens / lotrafilcon B lens
The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
干预措施: galyfilcon A prototype lens (Device)
galyfilcon A prototype lens / lotrafilcon B lens
The galyfilcon A prototype lenses will be worn during the first period and lotrafilcon B lenses will be worn during the second period. Each period consists of daily lens wear for one week.
干预措施: lotrafilcon B lens (Device)
lotrafilcon B lens / galyfilcon A prototype lens
The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.
干预措施: lotrafilcon B lens (Device)
lotrafilcon B lens / galyfilcon A prototype lens
The lotrafilcon B lenses will be worn during the first period and galyfilcon A prototype lenses will be worn during the second period. Each period consists of daily lens wear for one week.
干预措施: galyfilcon A prototype lens (Device)
结局指标
主要结局
Visual Acuity Monocular
时间窗: after 1 week of lens wear
Snellen monocular visual acuity measurement
Subjective Assessment of Quality of Vision
时间窗: after 1 week of lens wear
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
Visual Acuity Binocular
时间窗: after 1 week of lens wear
Snellen binocular visual acuity measurement
Subjective Assessment of Lens Comfort
时间窗: after 1 week of lens wear
Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.
次要结局
- Limbal Redness(after 1 week of lens wear)
- Bulbar Redness(after 1 week of lens wear)
- Subjective Assessment of Lens Comfort(10 minutes after lens insertion at time of initial lens fitting)