Clinical Evaluation of Two Monthly Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Subjective Rating of Overall Vision
研究概览
简要总结
The purpose of this study is to explore overall vision with BIOFINITY® ENERGYS™ contact lenses as compared to BIOFINITY® contact lenses after one week of wear.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an approved informed consent form (ICF);
- •Successful wear of BIOFINITY® (spherical) (or private label) contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
- •Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
- •Possess spectacles that provide a corrected visual acuity of 20/40 or better in both eyes (OU) and be willing to wear them (as needed);
- •Currently using digital devices (computer, tablet, and/or smart phone) for a minimum of 5 days per week and 4 hours per day;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, abnormality or disease that contraindicates contact lens wear;
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated;
- •Refractive, ocular, or intraocular surgery, as specified in the protocol;
- •Current or history of eye injury or disorders, as specified in the protocol;
- •Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
- •Habitual contact lens wear in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment;
- •Use of topical ocular medications that would require instillation during contact lens wear;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
BIOFINITY ENERGYS then BIOFINITY
Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
干预措施: Comfilcon A with Digital Zone Optics™ contact lenses (Device)
BIOFINITY ENERGYS then BIOFINITY
Comfilcon A with Digital Zone Optics™ contact lenses worn first, followed by comfilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
干预措施: Comfilcon A contact lenses (Device)
BIOFINITY then BIOFINITY ENERGYS
Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
干预措施: Comfilcon A with Digital Zone Optics™ contact lenses (Device)
BIOFINITY then BIOFINITY ENERGYS
Comfilcon A contact lenses worn first, followed by comfilcon A with Digital Zone Optics™ contact lenses. Each product will be worn bilaterally (in both eyes) for 7 days in a daily wear modality.
干预措施: Comfilcon A contact lenses (Device)
结局指标
主要结局
Subjective Rating of Overall Vision
时间窗: Day 7, each product
Overall vision was assessed binocularly (both eyes together) by the subject on a 10-point scale, where 1=poor and 10=excellent. Inferential testing was not planned for this primary effectiveness endpoint.
次要结局
- Over-refraction(Day 1 (Dispense), each product)