Clinical Validation of the Apollo Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Overall Comfort With Lens
研究概览
简要总结
The purpose of this study was to confirm the design specifications of a Test lens and validate its clinical performance.
详细描述
This was a double-masked, randomized, bilateral two-day crossover, dispensing study design. Subjects were randomized to wear the Test lens or Control lens bilaterally in random order and on a daily wear, single-use basis for a period of 2 days each.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Has read and understood the information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is an adapted soft contact lens wearer, having worn contact lenses for a minimum 4 weeks prior to the study
- •Has spectacle cylinder ≤1.00D in both eyes.
- •Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
- •Wears CLs in both eyes (monovision acceptable, but not monofit)
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination
- •Is willing to wear the study contact lenses for a minimum 8 hours on at least two consecutive days for each study pair.
排除标准
- •Has never worn contact lenses before.
- •Has any systemic disease affecting ocular health.
- •Is using any concomitant systemic or topical medications that will affect ocular health.
- •Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is participating in any other type of eye-related clinical or research study.
研究组 & 干预措施
Test Lens, then Control Lens
Participants wore Test Lens for 2 days, and then Control Lens for 2 days
干预措施: Control Lens (Device)
Test Lens, then Control Lens
Participants wore Test Lens for 2 days, and then Control Lens for 2 days
干预措施: Test Lens (Device)
Control Lens, then Test Lens
Participants wore Control Lens for 2 days, and then Test Lens for 2 days
干预措施: Test Lens (Device)
Control Lens, then Test Lens
Participants wore Control Lens for 2 days, and then Test Lens for 2 days
干预措施: Control Lens (Device)
结局指标
主要结局
Overall Comfort With Lens
时间窗: 2 days
Participants rated their overall comfort once after 2 days of wear a 0-100 integer scale, where 0=Cannot be tolerated and 100=Excellent comfort.
次要结局
- Overall Lens Handling(2 days)
- Overall Vision Quality(2 days)
- Overall Lens Fit Acceptance(2 days)
- Anterior Ocular Health - Corneal Staining Extent(2 days)