Comparison of Two Daily Disposable Contact Lenses Over 1-week of Wear
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 10
- 主要终点
- Subject Reported Ease of Removal
研究概览
简要总结
This is a one week 2x2 crossover study comparing delefilcon A with etafilcon A, with a primary hypothesis of comparing the handling of each lens. Additional secondary markers are measured looking at subjective comfort and vision of the lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject must be between 18 and 45 years of age (inclusive) with no presbyopic add.
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF).
- •The subject must be willing to wear the study lenses for at least 8 hours per day, 7 days per week.
- •The subject must be a current successful soft contact lens wearer in both eyes
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D in each eye.
- •The subject's refractive astigmatism must be less than or equal to 0.75D in both eyes.
- •The subject must have best corrected visual acuity of 20/30 (6/9) or better in each eye.
- •The subject must require a visual correction in both eyes (no monofit or monovision allowed).
- •The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- •No amblyopia.
- •No evidence of lid abnormality or infection (including blepharitis/meibomitis).
- •No conjunctival abnormality or infection.
- •No clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities).
- •No other active ocular disease.
排除标准
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- •Clinically significant (Grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Pregnancy or lactation.
- •No extended wear in the last 3 months.
- •Diabetes.
- •Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV).
- •Employee or family member of the staff of the investigational site.
研究组 & 干预措施
Delefilcon A/ Etafilcon A
6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear
干预措施: delefilcon A (Device)
Delefilcon A/ Etafilcon A
6-10 days of delefilcon A soft contact lens wear first, then 6-10 days of etafilcon A soft contact lens wear
干预措施: etafilcon A (Device)
Etafilcon A / Delefilcon A
6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear
干预措施: delefilcon A (Device)
Etafilcon A / Delefilcon A
6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear
干预措施: etafilcon A (Device)
结局指标
主要结局
Subject Reported Ease of Removal
时间窗: 6-10 Days
Measured on a 5 point-scale of excellence (excellent, very good, good, fair and poor) per a participant. Outcome is reported as aggregate number of subjects who reported Excellent/Very Good at their 1-week visit.
次要结局
- Binocular Snellen Visual Acuity(6-10 Days)
- Subject Reported Overall Vision(6-10 Days)
- Subject Reported Overall Comfort(6-10 Days)
- Overall Corneal Staining(6-10 Days)