Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
研究概览
简要总结
The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.
详细描述
Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign Informed Consent.
- •Adapted soft contact lens wearer.
- •Willing to wear contact lenses up to 12 hours and attend all study visits.
- •Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit
- •Contact lens prescription within the power range specified in the protocol.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
- •Any use of systemic or ocular medications that would contraindicate contact lens wear.
- •Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens.
- •History of herpetic keratitis, ocular surgery, or irregular cornea.
- •Known pregnancy.
- •Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
- •Participation in any clinical study within 30 days of Visit
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
时间窗: Hour 8
The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The time required for a dry spot to appear on the corneal surface after blinking is referred to as the tear film break-up time. Circular images were projected onto the contact lens using an Oculus Keratograph 5 and the tear film reflection was observed. PL NIK-BUT was recorded at the first sign of distortion. A longer tear film break-up time indicates a more stable tear film. One eye (right eye) contributed to the mean.
次要结局
- Total Wettability Score(Hour 8)