A Dispensing Clinical Trial of Invigor 1 Daily Disposable Lens Against Clariti 1-day Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Up Gaze Lag
研究概览
简要总结
The purpose of this study is to compare the dispensing performance of somofilcon A test 1 day contact lens against somofilcon A control 1 day contact lens.
详细描述
The purpose of this study is to evaluate the clinical performance of a silicone-hydrogel test contact lens compared to the commercially available silicone-hydrogel (control) contact lens when worn over one week for each lens type in a randomized, bilateral, cross-over, dispensing study on a daily disposable basis.
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
Double (participant and 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 (average wearing of 8 hours/day and 5 days/week) without the need of using rewetting drops
- •Requires spectacle lens spherical powers between -1.00 to -5.75 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.
- •Has a usable pair of spectacle lenses if required for transportation to the site for the initial visit
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 enrollment (by verbal confirmation at the screening visit).
结局指标
主要结局
Up Gaze Lag
时间窗: 1 week
Up Gaze Lag (measured in mm at 0.1mm steps)
Primary Gaze Lag
时间窗: 1 week
Primary Gaze Lag (measured in mm at 0.1mm steps)
Number of Participants With Lens Centration
时间窗: 1 week
Centration: Grade degree of Centration (Optimally Centered, Slightly Decentered (\<0.5mm Nasal (N), T (Temporal), S (superior), I (inferior), Extremely Decentered (\>0.5mm N T S I)
Post Blink Movement
时间窗: 1 week
Post Blink Movement (Amount of movement to the nearest 0.1mm immediately after the blink)
Number of Participants With Overall Lens Fit Impression
时间窗: 1 week
Overall Lens Fit Impression (2=Reduced movement, unacceptable, 1 = Reduced movement acceptable, 0 - Optimal movement, -1 =Excessive movement acceptable, -2 Excessive movement unacceptable
Overall Fit Acceptance
时间窗: 1 week
Overall fit acceptance assessed on a scale of 0-4 (0=unacceptable - cant be worn, 1 =Acceptable -Poor/worn under supervision, 2 =Acceptable -Fair, prefer refit, 3 = Acceptable-Good, 4 =Acceptable -Optimum
Push-Up Tightness
时间窗: 1 week
Push-Up Tightness (measured in 1% steps where 0% Falls from cornea without lid support, 50% optimum, 100% no movement)
次要结局
- Subjective Comfort Rating(1-week)