Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Preference
研究概览
简要总结
The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.
详细描述
The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.
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)
盲法说明
Both the participants and study investigators will be masked to the randomization schedule of the contact lenses used.
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 17 years of age and has full legal capacity to volunteer;
- •Has had a self-reported oculo-visual examination in the last two years;
- •Has read, understood, and signed the information consent letter;
- •Is willing and able to follow instructions and maintain the appointment schedule;
- •Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
- •Must be able to achieve 20/30 or better (in each eye) with the study lenses;
- •Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
- •Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
- •Has no more than 0.75 diopters of refractive astigmatism;
- •Has clear corneas and no active* ocular disease;
- •Has not worn lenses for at least 12 hours before the examination.
排除标准
- •Is presently participating in any other clinical or research study including eye related clinical or research study;
- •Has never worn contact lenses before.
- •Has any systemic disease affecting ocular health.
- •Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- •Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
- •Has any known sensitivity to fluorescein dye or products to be used in the study.
- •Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- •Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Is aphakic.
- •Has undergone corneal refractive surgery.
- •Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
研究组 & 干预措施
somofilcon A 1 day test lens
Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
干预措施: somofilcon A 1 day test lens (Device)
somofilcon A 1 day test lens
Subjects wearing the somofilcon A 1 day test lens for one week, either randomized as the first or second pair.
干预措施: somofilcon A 1 day control lens (Device)
somofilcon A 1 day control lens
Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.
干预措施: somofilcon A 1 day test lens (Device)
somofilcon A 1 day control lens
Subjects wearing the somofilcon A 1 day control lens for one week, either randomized as the first or second pair.
干预措施: somofilcon A 1 day control lens (Device)
结局指标
主要结局
Preference
时间窗: up to 1 week
Overall lens that subject prefers or no preference
Vision
时间窗: Up to 1 week
Visual acuity measured in logMAR
Comfort
时间窗: up to 1 week
Subjective comfort scored 0-100 (0=Cannot be worn, 100=Cannot be felt ever)
Subjective Vision
时间窗: up to 1 week
Subjective vision scored 0-100 (0=Extremely poor, 100=Excellent vision all the time)
Corneal Staining
时间窗: up to 1 week
Amount of staining observed on the cornea scored 0-4 (0=none, 4=severe) in 0.25 steps
Conjunctival Staining
时间窗: up to 1 week
Amount of staining observed on the conjunctiva scored 0-4 (0=none, 4=severe) in 0.25 steps
次要结局
未报告次要终点