NCT01695369已完成不适用
Clinical Comfort Evaluation of Biofinity and Acuvue Oasys Lenses
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
研究概览
简要总结
Evaluation of Comfilcon A and Senofilcon A Lenses
详细描述
Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Subjects must satisfy the following conditions prior to inclusion in the study:
- •Has had an 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 20/30 or better (in each eye) with their habitual vision correction
- •Currently wears soft contact lenses at least 3 days a week, 8 hours a day
- •Has clear corneas and no active ocular disease
- •Has not worn lenses for at least 12 hours before the examination
- •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 (e.g. entropion, ectropion, chalazia, recurrent styes)
- •No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
- •No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
- •No aphakia
- •Has prescription to match the available power range.
排除标准
- •Any of the following will render a subject ineligible for inclusion:
- •Greater than 0.75 of refractive astigmatism in either eye
- •Has never worn contact lenses before
- •Wears contact lenses on an extended wear basis
- •Has any systemic disease affecting ocular health
- •Is a known sufferer of ocular allergies
- •Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- •Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
- •Is aphakic
- •Has undergone corneal refractive surgery.
- •Is wearing monovision
- •Is participating in any other type of clinical or research study
- •Female who is currently pregnant or is breast-feeding
- •Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent
结局指标
主要结局
Subjective Responses for Comfort Rated on a 0-100 Visual Scale.
时间窗: Baseline Insertion, 10 Minutes, 5 hours and 10 hours
Subjective Patient Ratings measured using a Visual Analog Scale on a 0-100. (0=Cannot be worn. Causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever)
次要结局
未报告次要终点
研究者
研究点 (2)
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