NCT06119191已完成不适用
Clinical Evaluation of Comfilcon A Contact Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 10
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study was to confirm the clinical performance of a novel manufacturing process for comfilcon A contact lenses in habitual wearers over a one-month period of lens wear.
详细描述
This was a prospective, multiple day, double-masked (investigator and subject), randomized, bilateral re-fit parallel arm study comparing a Test Lens against an appropriate Control Lens. Participants were randomized to wear the Test or Control lens for 30±2 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had a self-reported oculo-visual examination in the last year.
- •Are at least 18 years of age and has full legal capacity to give their informed consent.
- •Have read and understood the informed consent letter.
- •Are willing and able to follow instructions and maintain the appointment schedule.
- •Have a contact lens spherical prescription between -0.50 D to -6.00 D (inclusive)
- •Are correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- •Have spectacle cylinder of ≤ 0.75 D in both eyes.
- •Is a habitual comfilcon A wearer and worn a comfilcon A lens for at least one month (minimum of 8 hours a day, 5 days per week)
- •Currently employ the use of a peroxide or multipurpose solution cleaning and disinfecting regimen in one of the following brand names:
- •Bausch and Lomb BioTrue Multi-Purpose Solution
- •Bausch and Lomb BioTrue Hydration Plus Multi-Purpose Solution
- •Bausch and Lomb ReNu Advanced Formulation Multi-Purpose Solution
- •Alcon Opti-Free Puremoist with Hydraglyde Multi-Purpose Solution
- •Alcon Opti-Free Replenish Multi-Purpose Solution
- •Alcon Clear Care Plus Hydrogen Peroxide Solution
- •Acuvue RevitaLens Multi-Purpose Solution
- •Have clear corneas and no active ocular disease.
- •Have not worn habitual lenses for at least 12 hours before the baseline/screening examination
- •Are willing to wear the study contact lenses for at least 8 hours per day, 5 days per week
排除标准
- •Have never worn contact lenses before.
- •Are currently wearing daily disposable contact lenses.
- •Have any systemic disease affecting ocular health.
- •Are using any systemic or topical medications that will affect ocular health.
- •Have any ocular pathology or abnormality that would affect the wearing of contact lenses.
- •Have any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- •Are aphakic.
- •Have undergone corneal refractive surgery.
- •Are participating in any other type of eye related clinical or research study.
- •Require a change in lens power from more than 1 diopter as dictated by over-refraction with their habitual lens prescription.
结局指标
主要结局
Visual Acuity
时间窗: 4 weeks
Monocular distance logMAR visual acuity at distance 4 meters under high illumination, high contrast conditions was measured at the 4 week timepoint of lens wear.
次要结局
未报告次要终点
研究者
研究点 (10)
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