DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
研究概览
简要总结
The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Must sign an Informed Consent document;
- •Wear toric soft contact lenses within the protocol-specified range;
- •Cylinder equal or higher than -0.75 diopters (D) in both eyes;
- •Have an acceptable fit with both study contact lenses;
- •Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
- •Best corrected visual acuity (BCVA) of 20/30 Snellen;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
- •Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •Require presbyopic correction;
- •Any ocular condition observed during examination at the enrollment visit;
- •History of herpetic keratitis, ocular surgery or irregular cornea;
- •Pregnant or lactating;
- •Participation in any clinical trial within 30 days of the enrollment visit;
- •Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
干预措施: Nelfilcon A toric contact lenses (Device)
DACP T, Then 1DAM A
Nelfilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
干预措施: Etafilcon A toric contact lenses (Device)
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
干预措施: Nelfilcon A toric contact lenses (Device)
1DAM A, Then DACP T
Etafilcon A toric contact lenses worn first, with nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
干预措施: Etafilcon A toric contact lenses (Device)
结局指标
主要结局
High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
时间窗: Day 10, each product
TCVA test was performed at 4 meters under high illumination (90%) using a Landolt ring test. For each acuity level, a series of single rings with gaps in one of four directions was presented and the percentage of correctly identified rings constituted the score. TCVA was measured in VA units and a higher TCVA value indicates an improvement in visual acuity. Both eyes contributed to the analysis.
次要结局
- Lens Oscillation at Blink at Day 10(Day 10, each product)