Multi-center Clinical Evaluation of PC 1-Day vs 1-Day Acuvue Moist
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Handling (Subjective Assessment)
研究概览
简要总结
The objective of this study is to compare the clinical performance of ProClear 1-Day versus 1-Day Acuvue Moist each for one week of daily disposable wear.
详细描述
The purpose of this cross-over study is to evaluate the clinical performance of the ProClear-1 Day in comparison with 1-Day Acuvue® Moist®. In particular, the study will focus on lens wearing comfort.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Is between 18 and 40 years of age (inclusive)
- •Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study.
- •Has had a self-reported visual exam in the last two years
- •Is an adapted soft CL (Contact Lens) wearer
- •Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so
- •Has a CL spherical prescription between - 1.00 and - 6.00 (inclusive)
- •Has less than 0.75D (Diopters) spectacle cylinder in each eye.
- •Is correctable to a visual acuity of 20/25 or better in both eyes
- •Has clear corneas and no active ocular disease
- •Has read, understood and signed the information consent letter.
- •Is willing to comply with the wear schedule (at least 40 hrs per week)
- •Is willing to comply with the visit schedule
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before.
- •Currently wears rigid gas permeable contact lenses.
- •Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- •Has a CL prescription outside the range of - 1.00 to -6.00D
- •Has a spectacle cylinder greater than -0.50D of cylinder in either eye.
- •Has best corrected spectacle distance vision worse then 20/25 in either eye.
- •Has any systemic disease affecting ocular health.
- •Is using any systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion
- •Has persistent, clinically significant corneal or conjunctival staining
- •Has active neovascularization or any central corneal scars.
- •Is aphakic.
- •Is presbyopic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye related clinical or research study.
结局指标
主要结局
Handling (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Handling on Insertion and Removal, Overall Handling for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very difficult, 10=very easy)
Overall Sensation of Smoothness (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Overall sensation of smoothness at 1 week wear for each pair when asked "How would you rate the overall sensation of smoothness (deposit resistance) of the first study lenses, over the last week of wear?" (Likert 1-5; 1=excellent, 2=good, 3=average, 4=below average, 5=poor)
Comfort (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Insertion Comfort, Comfort During Day, Comfort Prior to Removal, Comfort Overall for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very uncomfortable, 10=cannot feel)
Hydration (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Initial Hydration, Hydration During Day, Hydration Prior to Removal for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dehydrated, not hydrophilic, very dry, 10=very hydrated, ultra hydrophilic)
Vision Satisfaction (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Vision Satisfaction for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very unsatisfied, 10=very satisfied)
Dryness (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Dryness During Day, Dryness Prior to Removal, Overall Dryness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= very dry, 10=no dryness)
Vision Quality (Subjective Assessment)
时间窗: Baseline
Subjective Assessment: Visual quality on insertion at baseline for each pair using questionnaire and rated on subjective response scale (0-10; 0= clear vision, 10=perfectly sharp)
Eye Whiteness/Redness (Subjective Assessment)
时间窗: 1 Week
Subjective Assessment: Eye Whiteness/Redness for each pair using questionnaire and rated on subjective response scale. (0-10; 0= significant redness, 10=totally white)
Overall Satisfaction for Lens
时间窗: 1 Week
Subjective Assessment: Satisfaction overall at 1 Week wear for each pair when asked "Overall, how satisfied was the subject with the study lenses, during the last week, with regards to: Overall?" (Likert 1-4; 1=completely satisfied, 2=somewhat satisfied, 3=somewhat dissatisfied, 4=completely dissatisfied)
次要结局
未报告次要终点