NCT04050618已完成不适用
Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 12
- 主要终点
- Subjective Overall Comfort Rating
研究概览
简要总结
To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.
详细描述
This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Subjects will be masked to lens type. Investigators will be unmasked.
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
- •Be a currently adapted soft contact lens wearer (>1 month of lens wear).
- •Be at least 18 years of age.
- •Refractive astigmatism <1.00D in both eyes.
- •Have clear corneas and be free of any anterior segment disorders.
- •Be correctable through spherocylindrical refraction to 20/25 or better in each eye.
- •Contact lens sphere requirement between -1.00D and -6.00D (inclusive).
- •Require visual correction in both eyes (monovision allowed, no monofit).
- •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 strabismus
- •No evidence of lid abnormality or infection
- •No conjunctival abnormality or infection that would contraindicate contact lens wear
- •No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
- •No other active ocular disease.
- •Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.
- •Willing to comply with the wear and study visit schedule.
排除标准
- •Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics
- •Require toric or multifocal contact lenses.
- •Previously shown a sensitivity to any of the study solution components.
- •Any systemic or ocular disease or allergies affecting ocular health.
- •Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.
- •Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- •Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
- •Keratoconus or other corneal irregularity.
- •Aphakia or amblyopia.
- •Have undergone corneal refractive surgery or any anterior segment surgery.
- •Abnormal lacrimal secretions.
- •Has diabetes.
- •Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- •History of chronic eye disease (e.g. glaucoma).
- •Pregnant or lactating or planning a pregnancy at the time of enrolment.
- •Participation in any concurrent clinical trial or in last 30 days.
结局指标
主要结局
Subjective Overall Comfort Rating
时间窗: Four weeks
Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses
次要结局
- Average Wearing Time(Four weeks)
- Average Comfortable Wearing Time(Four weeks)
- Lens Centration(Four weeks)
- Corneal Coverage(Four weeks)
- Post-Blink Movement(Four weeks)
- Lens Tightness - Push-up Test(Four weeks)
- Overall Lens Fit Acceptance(Four weeks)
- Rating of Lens Surface Wettability(Four weeks)
- Presence of Film Deposits(Four weeks)
- Number of White Spot Deposits(Four weeks)
- Primary Gaze Lag(Four weeks)
- Comfort Throughout the Day(Day 26 - 8:00pm)
研究者
研究点 (12)
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