NCT02089191已完成不适用
Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
研究概览
简要总结
The purpose of this study is to evaluate tear film stability of DAILIES® AquaComfort Plus® (DACP) compared to MyDay® after 12 hours of lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
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
- •Must sign an Informed Consent form;
- •Adapted, current soft contact lens wearer;
- •Required contact lens prescription within the power range specified in the protocol (+6.00 to -10.00 diopters (D));
- •Cylinder ≤ -1.00 D in both eyes at Visit 1;
- •Vision correctable to 0.1 logarithm of the Minimum Angle of Resolution (logMAR) or better in each eye at distance with pre-study lenses at Visit 1;
- •Willing to wear study lenses up to 12 hours and attend all study visits;
- •Able to be successfully fitted with study lenses;
- •Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses;
- •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 for which contact lens wear could be contraindicated, as determined by the Investigator;
- •Use of artificial tears and rewetting drops during the study;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Any abnormal ocular condition observed during Visit 1;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Pregnant or lactating;
- •Participation in any clinical study within 30 days of Visit 1;
- •Current MyDay® or DAILIES® AquaComfort Plus® lens wearer;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Time Post-blink to 15% Distortion of the Projected Rings After 12 Hours of Lens Wear
时间窗: Day 1, Hour 12, each period
The participant blinked twice, then kept eye open. Circular images were projected onto tear film layer located on the surface of the contact lens. Measuring software automatically detected areas where the tear film destabilized after the blink. The time to 15% destabilization of the tear film was calculated. A longer time indicates a more stable tear film. The right eye was evaluated.
次要结局
- Mean Speed of Tear Film Break-up at 15 Seconds Post-blink After 12 Hours of Lens Wear(Hour 12)
研究者
研究点 (1)
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