NCT01386008终止不适用
Evaluation of DW Silicone Hydrogel Lens Compared to DW Silicone Hydrogel Lens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 4
- 主要终点
- Ocular Health
研究概览
简要总结
The purpose of this study is to evaluate the performance of the investigational CooperVision silicone hydrogel lens compared to a currently-marketed silicone hydrogel contact lens up to 30 days of daily lens wear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •Be at least 18 years of age as of the date of evaluation for the study.
- •Not using any ocular medications
- •Have a self-reported full eye examination within 2 years.
- •read the Informed Consent
- •be given an explanation of the Informed Consent
- •indicate understanding of the Informed Consent
- •signed the Informed Consent document.
- •Be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- •Be an adapted, current full-time silicone hydrogel or soft contact lens wearer. An adapted full-time wearer is defined as wearing contact lenses on a daily basis for at least 8 hours per day for at least one month prior to participation in the study.
- •Possess wearable and visually functional eyeglasses.
- •Be in good general health, based on his/her knowledge.
- •Require spectacle lens powers between -1.00 and -6.00 diopters sphere with no more than 0.75 diopter of refractive astigmatism in order to have the best spherical equivalent power of -6.50 or less.
- •Be willing to wear contact lenses in both eyes.
- •Have manifest refraction Snellen visual acuities (VA) equal to or better than 20/25 (less than or equal to LogMAR 0.10) in each eye.
- •Upon completing the fitting process with the lenses to be worn in the study, have contact lens Snellen VA equal to or better than 20/30 in each eye.
排除标准
- •Wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes. NOTE: Subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis.
- •Any active participation in another one-day clinical trial within 7 days prior to this study or another dispensing trial within 30 days prior to this study.
- •Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next month.
- •Has a known sensitivity to ingredients used in the over the counter contact lens care approved for use in the study.
- •Previous refractive surgery/anterior segment surgery; or current or previous orthokeratology treatment or irregular cornea.
- •Is aphakic or pseudophakic.
- •Unable to achieve a satisfactory fit with the lens designs used in the study
- •Ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermia, keratoconus or type II diabetes.
- •The need for topical ocular medications or any medication which might contradict contact lens wear or which would require the lenses to be removed during the day.
- •The presence of clinically anterior segment infection, inflammations or abnormalities; such as iritis; or any infection of the eye, lids, or associated structures.
- •A history of herpetic keratitis.
- •A known history of corneal hypoesthesia (reduced corneal sensitivity) or active corneal ulcer, corneal infiltrates or fungal infection.
- •A history of papillary conjunctivitis that has interfered with contact lens wear.
- •Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- •Pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining > grade 2
- •Pterygium
- •Corneal scars within the visual axis
- •Corneal edema or corneal staining ≥ grade 2
- •Neovascularization or ghost vessels > 1.0 mm in from the limbus
- •Giant papillary conjunctivitis (GPC) of > grade
- •Seborrheic eczema, seborrheic conjunctivitis or blepharitis
研究组 & 干预措施
enfilcon A + senofilcon A
Other
Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
干预措施: senfilcon A contact lens (Device)
enfilcon A + senofilcon A
Other
Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
干预措施: investigational enfilcon A (Device)
结局指标
主要结局
Ocular Health
时间窗: Change from baseline over 30 days measured at V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Ocular health determined by biomicroscopy recorded on a severity scale (0-4) for change from baseline over 30 days.
Subjective Comfort Preference - Participants Preference Response
时间窗: V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30)
Subjective responses of participants administered by questionnaire and measured on a linear scale (0-100) measured at each visit.
次要结局
- Investigator Surface Preference(V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30))
- Investigator Fit Preference(V1 (Initial), V2 (Day-7), V3 (Day-14), V4 (Day-30))
研究者
研究点 (4)
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