Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Front Surface Wettability, by Category
概览
简要总结
The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.
详细描述
Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Lens will be provided with investigational product labeling
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
- •Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
- •Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any condition that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
- •History of refractive surgery or plan to have refractive surgery during the study.
- •Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- •Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Front Surface Wettability, by Category
时间窗: Dispense; Week 1 Follow-up
Front surface wettability (i.e., assessment of the disruption of the front surface wettability of the contact lens) was assessed by the investigator for each eye individually. Front surface wettability was collected on a 5-point scale, where where Grade 0 = a smooth uniformly reflecting surface, Grade 1 = a coarse hazy surface which seems resolved momentarily with each blink and becomes exacerbated with staring, Grade 2 = one stable dry (non-wetting) area of some magnitude, Grade 3 = more than one stable dry (non-wetting) area of some magnitude, and Grade 4 = non-wettable lens surface. No formal hypothesis was predefined for the primary endpoint. No inferential testing was performed.
次要结局
未报告次要终点