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
- 1
- 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.
研究组 & 干预措施
somofilcon A then stenfilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
干预措施: comfilcon A (Device)
somofilcon A then stenfilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
干预措施: somofilcon A (Device)
somofilcon A then stenfilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear somofilcon A daily disposable test lens for 1 week of daily wear and stenfilcon A daily disposable test lens for 1 week of daily wear.
干预措施: stenfilcon A (Device)
stenfilcon A then somofilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
干预措施: comfilcon A (Device)
stenfilcon A then somofilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
干预措施: somofilcon A (Device)
stenfilcon A then somofilcon A contact lens
Participants were fitted with comfilcon A lens on a daily wear, reusable basis for 1 month, then randomized to wear stenfilcon A daily disposable test lens for 1 week of daily wear and somofilcon A daily disposable test lens for 1 week of daily wear.
干预措施: stenfilcon A (Device)
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)
- Number of Participants With Horizontal Lens Centration Grade(Baseline (after 5 minutes of lens dispense))
- Number of Participants With Vertical Lens Centration Grade(Baseline (After 5 minutes of lens dispense))
- Number of Participants With Lens Corneal Coverage Grade(Baseline (after 5 minutes of lens dispense))
- Number of Participants With Post-Blink Movement Grade(Baseline (after 5 minutes of lens dispense))
- Investigator Lens Fit Acceptance(Baseline (after 5 minutes of lens dispense))