Comparative Evaluation of Contact Lens Centering of DAILIES® AquaComfort Plus® Versus 1-DAY ACUVUE® MOIST®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 主要终点
- Mean Investigator-Rated Lens Centration
研究概览
简要总结
The purpose of this study is to evaluate lens centration and subjective impressions of DAILIES® AquaComfort Plus® (DACP) lenses compared to 1-DAY ACUVUE® MOIST® (1DAM) lenses in ball sports players.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Those who can understand the clinical study objectives and provide written informed consent. Legal representative or parental consent required if under age 20
- •Those who regularly wear soft contact lenses in both eyes for a minimum of 8 hours per day and 5 days per week
- •Those who play ball sports at least 1 day per week
- •Those who need vision correction because of myopia or mild myopic astigmatism, who are eligible for use of the study device, and who can attain a visual acuity of at least 1.0 with correction
- •Other protocol-defined inclusion criteria may apply
排除标准
- •Those who regularly wear the study device
- •Those who require ocular treatment with eye drops
- •Those who have a condition contraindicating soft contact lens wear, such as eye irritation
- •Those who have had ocular disorder or ocular surgery that may affect soft contact lens wear within 3 months before the start of the study
- •Those who are participating in another clinical study or research or have a plan of such participation during the present study
- •Women who are pregnant or intend to become pregnant during the study
- •Other protocol-defined exclusion criteria may apply
研究组 & 干预措施
DACP, then 1DAM
Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
干预措施: Nelfilcon A contact lenses (Device)
DACP, then 1DAM
Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
干预措施: Etafilcon A contact lenses (Device)
1DAM, then DACP
Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
干预措施: Etafilcon A contact lenses (Device)
1DAM, then DACP
Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
干预措施: Nelfilcon A contact lenses (Device)
结局指标
主要结局
Mean Investigator-Rated Lens Centration
时间窗: After 1 week of wear
Lens centration was assessed by the investigator using slit-lamp microscopy and rated on a 5-point scale, where 0=Optimal and 4=Severe decentration. Both eyes contributed to the mean.
次要结局
- Average Subjective Ratings Score (Lens Handling and Overall Vision)(After 1 week of wear)
- Mean Investigator-Rated Lens Fit(After 1 week of wear)
- Average Subjective Ratings Score (Lens Wearing Conditions and Visual Performance During Ball Sports)(After 1 week of wear)