A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
详细描述
This study is a 20-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
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
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A person is eligible for inclusion in the study if he/she:
- •Has had a self-reported oculo-visual examination in the last two years
- •Is 50 years of age or greater and has full legal capacity to volunteer
- •Is able to read and understand the informed consent
- •Is willing and able to follow instructions and maintain the appointment schedule
- •Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
- •Near Add Power requirement of +2.25D or greater
- •Has spectacle cylinder 0.75 D in both eyes
- •Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- •Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
- •Has clear corneas and no active ocular disease
- •Has not worn gas permeable contact lenses for 1 month prior to the study
排除标准
- •A person will be excluded from the study if he/she:
- •Has never worn contact lenses before
- •Has any systemic disease affecting ocular health
- •Is using any systemic or topical medications that will affect ocular health
- •Has any ocular pathology or abnormality that would affect the wearing of contact lenses
- •Is aphakic (i.e. missing their natural lens inside their eye)
- •Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
- •Has undergone corneal refractive surgery
- •Is participating in any other type of eye related clinical or research study.
结局指标
主要结局
Visual Acuity
时间窗: 4 days
Visual acuity for test and control lens was measured at Distance, Intermediate, and Near conditions by LogMAR.
Visual Performance
时间窗: 4 days
Subjective assessment of visual performance for Distance, Intermediate and Near conditions was collected on a scale of 0-100 (Scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time).
次要结局
- Dryness(4 days)
- Comfort(4 days)
- Subjective Satisfaction(4 days)
- Subjective Preference for Near Vision(4 days)
- Subjective Preference for Comfort(4 days)
- Subjective Preference for Intermediate Vision(4 days)
- Lens Handling(4 Days)
- Subjective Preference for Distance Vision(4 days)
- Subjective Overall Vision Preference(4 days)
- Limbal Hyperemia(4 days)
- Average Daily Wearing Time(4 days)
- Bulbar Hyperemia(4 days)
- Lens Fit(4 days)