Clinical Characterization of an Investigational Soft Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Front Surface Wettability, by Category
研究概览
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 2 weeks of daily wear.
详细描述
Participants will attend a Screening visit, a Dispense visit (0 to 4 days later), and a follow-up visit approximately 2 weeks after the Dispense 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
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 weekly/monthly 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.
- •Habitual contact lenses worn in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- •Any use of topical ocular medications or artificial tear or rewetting drops that would require instillation during contact lens wear.
- •Monovision or multifocal contact lens wear.
- •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 2 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 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