On-Eye Evaluation of Contact Lens Axis Location
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear
研究概览
简要总结
The purpose of this study was to evaluate the axis location of toric contact lenses after 3 minutes of wear. During this 1-visit study, each participant wore 3 pairs of study lenses of various design iterations (2-87-1, 2-87-2, 2-87-3) for an exposure time of approximately 30 minutes each. Each pair consisted of lenses of the same design iteration, 1 lens with embossed mark [TEST1 (T1), TEST3 (T3), TEST5 (T5)], worn on the right eye, and 1 lens without embossed mark [TEST2 (T2), TEST4 (T4), and TEST6 (T6)] worn on the left eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Sign written Informed Consent.
- •Best corrected distance visual acuity greater than or equal to 20/25 in each eye.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History of any ocular surgery or ocular injury within 12 weeks of enrollment for this study.
- •Anterior segment disease, infection, inflammation, or abnormality that contraindicates contact lens wear.
- •History of herpetic keratitis.
- •Slit-lamp findings at baseline as specified in the protocol.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, including ocular medications that require instillation during contact lens wear.
- •Clinically significant dry eye not responding to treatment.
- •History of refractive surgery.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percentage of Lenses With Axis Orientation ≤ 10 Degrees From Ideal Location After 3 Minutes of Wear
时间窗: Day 1
Axis orientation (the rotational positioning of the lens on the eye) was indicated by an axis mark. The actual location of the axis mark was evaluated during slit lamp review and compared to the ideal location for the axis mark, with the difference measured in degrees (0 to +/- 180). The ideal location for the axis mark was iteration-specific (either 6 o'clock or 3 and 9 o'clock). This outcome measure was pre-specified for the embossed lenses only (TEST1, TEST3, and TEST5).
次要结局
- Lens Awareness(Day 1)
- Handling on Removal(Day 1)