Clinical Evaluation of Invigor Toric 1-Day Contact Lenses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Toric Fit Preference
研究概览
简要总结
An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.
详细描述
A non-dispensing, double-masked, randomized, contralateral study comparing the 1-day toric test contact lens against the 1-day toric control contact lens to evaluate the clinical performance over one hour of lens wear. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye for each pair of lenses.
Each subject will be asked to wear four pairs of contact lenses in the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Has had a self-reported oculo-visual examination in the last two years.
- •Is at least 18 years of age 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 correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 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
- •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.
结局指标
主要结局
Toric Fit Preference
时间窗: 1 hour
Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Visibility of Toric Mark
时间窗: 1 hour
Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Rotational Recovery
时间窗: 1 hour
Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Fit Acceptance
时间窗: 1 hour
Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Degree of Lens Orientation
时间窗: 1 hour
Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
Toric Stability
时间窗: 1 hour
Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).
次要结局
- Lens Push-Up(1 hour)
- Primary Lens Gaze Lag(1 hour)
- Measurement of Lens Movement(1 hour)
- Measurement of Lens Horizontal Centration(1 hour)
- General Lens Fit Acceptance(1 hour)
- Measurement of Lens Vertical Centration(1 hour)
- Up Gaze Lag(1 hour)
- General Lens Fit Preference(1 hour)