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
- Subjective Scores of Comfort on Insertion
研究概览
简要总结
This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.
详细描述
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will only be eligible for the study if:
- •They are between 18 and 40 years of age (inclusive).
- •They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- •They are willing and able to follow the protocol.
- •They are an existing soft reusable spherical contact lens wearer in both eyes.
- •They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
- •They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
- •They own a wearable pair of spectacles and wear them on the day of the initial visit.
- •They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
- •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.
- •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 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 other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
结局指标
主要结局
Subjective Scores of Comfort on Insertion
时间窗: 1 week
Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
时间窗: 4 weeks
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
次要结局
- Subjective Scores on Comfort Before Removal(1 week)
- Number of Participants With Horizontal Lens Centration Grade(1 week)
- Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use(4 weeks)
- Number of Participants With Vertical Lens Centration Grade(1 week)
- Number of Participants With Lens Corneal Coverage Grade(1 week)
- Number of Participants With Post-Blink Movement Grade(1 week)
- Investigator Lens Fit Acceptance(1 week)
- Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use(4 weeks)
- Subjective Scores on Overall Comfort(1 week)
- Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear(4 weeks)
- Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear(4 weeks)
- Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear(4 weeks)
- Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use(4 weeks)
- Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear(4 weeks)