A Two-Week Crossover Dispensing Evaluation Of Orion Daily Wear Soft Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Subjective Response for Vision Satisfaction
研究概览
简要总结
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear.
详细描述
The primary objective of the study is to evaluate the clinical performance of test lens (Orion) in comparison with control lens (Gemini) over a period of two weeks of wear. This is a double-masked, randomized, bilateral, two-week crossover, dispensing study.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is at least 18 years of age and has full legal capacity to volunteer.
- •Is no greater than 55 years of age.
- •Has read and understood the information consent letter.
- •Is willing and able to follow instructions and maintain the appointment schedule.
- •Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
- •Has spectacle cylinder ≤1.00D in both eyes.
- •Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
- •Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/20 in each eye.
- •Wears CLs in both eyes (monovision acceptable, but not monofit)
- •Has clear corneas and no active ocular disease.
- •Has not worn lenses for at least 12 hours before the examination.
- •Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week
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 strabismus/amblyopia.
- •Has undergone corneal refractive surgery.
- •Is pregnant, lactating or planning a pregnancy.
- •Is participating in any concurrent clinical or research study.
研究组 & 干预措施
Orion then Gemini
Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
干预措施: Orion daily disposable contact lens (Device)
Orion then Gemini
Subjects will be randomized to wear Orion daily disposable contact lens then Gemini daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
干预措施: Gemini daily disposable contact lens (Device)
Gemini then Orion
Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
干预措施: Orion daily disposable contact lens (Device)
Gemini then Orion
Subjects will be randomized to wear Gemini daily disposable contact lens then Orion daily disposable contact lens for 2 weeks in this randomized, cross-over bilateral dispensing study.
干预措施: Gemini daily disposable contact lens (Device)
结局指标
主要结局
Subjective Response for Vision Satisfaction
时间窗: Baseline - After 10 minutes of lens dispense
Subjective Response for Vision Satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Satisfaction
时间窗: 2 Weeks - at night
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Quality
时间窗: 2 weeks - Night Driving
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Subjective Response for Overall Vision Satisfaction
时间窗: 2 Weeks
Subjective Response for Vision satisfaction assessed on 7-point Likert (Very satisfied, Satisfied, Somewhat satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Dissatisfied, Very Dissatisfied)
Subjective Response for Overall Vision Quality
时间窗: Baseline - After 10 minutes of lens dispense
Subjective Response for Overall Vision quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
Subjective Response for Overall Vision Quality
时间窗: 2 weeks
Subjective Response for Overall Vision Quality assessed on a 0-100 scale (0- Unacceptable, 100- Excellent Vision)
次要结局
- Subjective Overall Lens Handling(2 weeks)
- Post-blink Movement(2 weeks)
- Lens Horizontal Mobility Rating(2 weeks)
- Corneal Staining Extent(2 weeks)
- Overall Lens Fit Acceptance(2 weeks)
- Lens Handling Satisfaction(2 weeks)
- Subjective Overall Comfort Satisfaction(2 Weeks)
- Subjective Preference for Comfort(2 weeks)
- Lens Surface Wettability Performance(2 weeks)
- Horizontal Lens Centration(2 weeks)
- Vertical Lens Centration(2 weeks)
- Subjective Overall Comfort Satisfaction(Baseline - After 10 minutes of lens dispense)
- Lens Surface Wettability Performance(Baseline - After 10 minutes of lens dispense)
- Horizontal Lens Centration(Baseline - After 10 minutes of lens dispense)
- Vertical Lens Centration(Baseline - After 10 minutes of lens dispense)
- Post-blink Movement(Baseline - after 10 minutes of lens dispense)
- Lens Horizontal Mobility Rating(Baseline - after 10 minutes of lens dispense)
- Corneal Staining Extent(Baseline - after 10 minutes of lens dispense)
- Overall Lens Fit Acceptance(Baseline - after 10 minutes of lens dispense)