NCT03306641已完成不适用
A One-Week Crossover Dispensing Evaluation of Gemini Daily Wear Soft Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Lens Fit Acceptance
研究概览
简要总结
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).
详细描述
The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.
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)
盲法说明
The contact lenses coding will be masked to both the investigator and subject. If standard labeling does not sufficiently mask the study material then over-labeling will be performed.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Is no greater than 55 years of age.
- •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 lenses for a minimum of 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 20/25 in each eye.
- •Wears CLs in both eyes (monvision 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 per day/6 days per week
排除标准
- •Has never worn contact lenses before.
- •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 (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 strabismus/amblyopia.
- •Has undergone corneal refractive surgery.
- •Is pregnant, lactating or planning a pregnancy.
- •Is participating in any concurrent clinical or research study.
结局指标
主要结局
Lens Fit Acceptance
时间窗: 1-Week
Overall lens fit acceptance was measured on a scale of 0-4 in 0.25 steps (0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=Optimum)
次要结局
未报告次要终点
研究者
研究点 (2)
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