Clinical Performance Evaluation of Two Daily Disposable Silicone Hydrogel Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
研究概览
简要总结
The purpose of this study is to evaluate the rotational behavior of DT1 Toric contact lenses.
详细描述
This is a single visit, non-dispense study where subjects will be exposed to the test and control lenses for approximately 1 hour each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
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
- •Current wearer of any commercial soft daily wear contact lens with at least 3 months of wearing experience with a minimum wearing time of 5 days per week and 8 hours per day.
- •Requiring contact lens (manifest refraction) of a cylindrical power of -0.75 to -2.50 diopter cylinder (DC).
- •Best corrected distance visual acuity 20/25 or better Snellen in each eye (as determined by manifest refraction at screening).
- •Willing to NOT use rewetting/lubricating drops at any time during the study. Other protocol-defined inclusion criteria may apply.
排除标准
- •Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- •History of refractive surgery or plan to have refractive surgery during the study or irregular cornea in either eye.
- •Eye injury in either eye within 12 weeks immediately prior to enrollment for this trial.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Test, then Control
DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
干预措施: DT1 Toric contact lenses (Device)
Test, then Control
DT1 Toric contact lenses worn first, followed by AO1DfA contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
干预措施: AO1DfA contact lenses (Device)
Control, then Test
AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
干预措施: DT1 Toric contact lenses (Device)
Control, then Test
AO1DfA contact lenses worn first, followed by DT1 Toric contact lenses, as randomized. Each product will be worn in both eyes for approximately 1 hour.
干预措施: AO1DfA contact lenses (Device)
结局指标
主要结局
Percent of DT1 toric lenses with axis orientation within ±30° from the intended axis, 10 min after lens insertion
时间窗: Day 1, 10 minutes after lens insertion, each product
A slit lamp will be used to observe axis orientation.
次要结局
未报告次要终点