Clinical Validation Study of Biofinity Multifocal Toric Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
This is a study to evaluate the clinical performance and subjective acceptance of an investigational contact lens (test), compared to a marketed lens (control) in an in-office setting.
详细描述
This is a study to evaluate the clinical performance (including visual acuity, subjective assessments of visual performance, comfort ratings, vision preference and lens fit) of a comfilcon A investigational contact lens (test) compared to a control contact lens, in a non-dispensing setting. The main study hypothesis is the test contact lens will not be clinically inferior to the 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
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is between ages 40-75 years, inclusive and has full legal capacity to volunteer.
- •Has read and understood the information consent letter. Is willing and able to follow instructions and maintain the appointment schedule.
- •Is able to participate in Parts A and B related to this work.
- •Has a contact lens spherical prescription between +10.00 to 10.00D (inclusive).
- •Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
- •Has astigmatism between of -0.75 and -5.75DC (based on the calculated ocular refraction) in each eye.
- •Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/25 best-corrected.
- •Currently wears soft contact lenses.
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination.
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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- •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 participating in any other type of eye related clinical or research study.
研究组 & 干预措施
Comfilcon A lens (test)
Subjects are randomized to wear comfilcon A lens for up to 3 hours, either as first or second lens during this cross over study.
干预措施: Comfilcon A lens (test) (Device)
Omafilcon B Lens (control)
Subjects are randomized to wear omafilcon B lens for up to 3 hours, either as first or second lens during this cross over study.
干预措施: Omafilcon B lens (control) (Device)
结局指标
主要结局
Visual Acuity
时间窗: up to 3 hours
Visual acuity is assessed for test and control lens on a logMAR chart
次要结局
- Subjective Assessment of Visual Performance: Distance Day-time Navigation Tasks for Vision Quality and Clarity(up to 3 hours)
- Subjective Assessment of Visual Performance: Intermediate / Computer Task for Vision Quality and Clarity(up to 3 hours)
- Subjective Assessment of Visual Performance: Near Vision for Vision Quality and Clarity(up to 3 hours)