Daily Wear (DW) Evaluation of Lotrafilcon B in a Modified Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 主要终点
- Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
研究概览
简要总结
The purpose of this study is to demonstrate that Lotrafilcon B AIR OPTIX® AQUA sphere modified design lenses are noninferior to Lotrafilcon B AIR OPTIX® AQUA in overall lens fit by comparing the percent of subjects satisfying the "no re-fit" criteria in each treatment group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must sign an Informed Consent Document;
- •Myopic, wear AIR OPTIX® AQUA lenses in the range of -1.00 to -5.00 diopters (D) in both eyes, and willing to comply with the wearing schedule;
- •Manifest cylinder less than or equal to 0.75 D;
- •Able to achieve best corrected visual acuity (BCVA) of 20/25 (Snellen) or better in each eye at distance;
- •Able to achieve distance visual acuity of at least 20/40 in each eye with habitual and study lenses;
- •Wearing spherical AIR OPTIX® AQUA lenses in both eyes for at least 3 months (at least 8 hours per day, at least 5 days per week), wearing the habitual lenses for a minimum of 4 hours prior to the baseline study visit, and achieving an acceptable or optimal fit at baseline visit with habitual lenses in both eyes;
- •Other protocol-defined criteria may apply.
排除标准
- •Current soft contact lens wearer who regularly sleeps in lenses (1 or more nights per week);
- •Any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear within 6 months prior to enrollment;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear;
- •History of herpetic keratitis;
- •History of corneal or refractive surgery or irregular cornea;
- •A pathologically dry eye that precludes contact lens wear;
- •Monocular (only one eye with functional vision);
- •Monovision correction;
- •History of intolerance or hypersensitivity to any component of the test articles or associated materials;
- •Concurrent participation in a contact lens or contact lens care product clinical trial or within the previous 30 days;
- •Eye injury or ocular or intra-ocular surgery within 6 months prior to enrollment;
- •Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the study lenses or affect the results of this study;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Proportion of Subjects Satisfying the 'no Re-fit' Criteria in Both Eyes
时间窗: Dispense (Day 0), Week 1
With the contact lens on eye, the investigator assessed the lens fit immediately post-blink and following lower lid margin push-up with the lower lid using a 5-point scale, where -2 = Unacceptably tight (reduced movement, unacceptable), -1 = Acceptably tight (reduced movement, acceptable), 0 = Optimal fit / movement, +1 = Acceptably loose (excessive movement, acceptable), and +2 = Unacceptably loose (excessive movement, unacceptable). To meet the definition of "no re-fit," an eye had to have an acceptable or optimal overall lens fit with the study lens, as well as be within 1 grade of the overall lens fit assessed with the habitual lens at baseline. Proportion of subjects is reported as a percentage.
次要结局
未报告次要终点