A Clinical Comparison of Two Daily Disposable Soft Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Lens Fit - Corneal Coverage
研究概览
简要总结
The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
详细描述
This study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. Fifty-five subjects will wear each lens brand for approximately one week in random order. Lenses were worn on a daily wear, daily disposable basis.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •They are between 18 and 40 years of age (inclusive).
- •They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- •They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
- •They own a wearable pair of spectacles and wear them on the day of the initial visit.
- •At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- •They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- •They agree not to participate in other clinical research for the duration of the study.
排除标准
- •They have an ocular disorder, which would normally contra-indicate contact lens wear.
- •They have a systemic disorder, which would normally contra-indicate contact lens wear.
- •They are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study.
- •They are aphakic.
- •They have had corneal refractive surgery.
- •They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- •They are pregnant or breastfeeding.
- •They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear
- •They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- •They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
结局指标
主要结局
Lens Fit - Corneal Coverage
时间窗: One Week
Assessment of corneal coverage of lens (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Lens Movement
时间窗: One Week
Lens movement assessed per corneal coverage (extremely inadequate, slightly inadequate, optimum, slightly excessive, extremely excessive)
Lens Fit - Horizontal Centration
时间窗: One Week
Assessment of horizontal centration of lens (extremely nasal, slightly nasal, optimum, slightly temporal, extremely temporal)
Lens Fit - Vertical Centration
时间窗: One Week
Assessment of vertical centration of lens (extremely inferior, slightly inferior, optimum, slightly superior, extremely superior)
次要结局
- Subjective Score for Vision(One week)