NCT00597467已完成不适用
An Open-Labeled, Multi-Center, Randomized Investigation of the VISA (Comfilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens for Use in a 7 Day Extended Wear Regimen
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 42
- 主要终点
- Frequency of serious and significant AEs
研究概览
简要总结
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses.
详细描述
To compare the safety and efficacy of the CVI silicone-hydrogel lens worn on an extended wear basis for a period of up to 7 days and 6 nights with the Acuvue 2 soft contact lenses in this open-labeled randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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.
- •Require lens powers between -0.50 and -6.00 diopters sphere with no more than 1.00 diopter of refractive astigmatism and be willing to wear lenses in both eyes.
- •Be correctable to visual acuities of at least 20/25 in each eye with spectacles.
- •Be in good general health, based on his/her knowledge.
- •Be able and willing to adhere to the instructions set forth in this protocol and able to keep all specified appointments.
- •Possess wearable and visually functional eyeglasses.
排除标准
- •Previously unsuccessful with contact lens wear.
- •Rigid gas permeable contact lens wear within the past 12 months.
- •Previous refractive surgery; current or previous orthokeratology treatment.
- •Subject is wearing lenses in a modified monovision modality (multifocal lens in one eye). NOTE: subjects may not wear monovision lenses at any time during the study unless they are wearing spherical monovision lenses prior to enrollment.
- •Aphakia, keratoconus or an irregular cornea.
- •A known history of corneal hypoesthesia
- •Clinically significant (grade 3 or 4) anterior segment abnormalities or any infection of the eye, lids, or associated structures.
- •Ocular or systemic disease or need for medication which might interfere with contact lens wear. i.e., Sjögren's syndrome, type II diabetes, etc.
- •Slit lamp findings that would contraindicate contact lens wear, including but not limited to:
- •History of corneal ulcer, corneal infiltrates or fungal infections.
- •Pterygium, pinguecula or corneal scars within the visual axis
- •Pathological dry eye or associated findings (examples: Sjögren's syndrome, lupus erythematosus, sclerodermia)
- •Neovascularization or ghost vessels > 1mm in from the limbus
- •Seborrheic eczema, seborrheic conjunctivitis
- •History of papillary conjunctivitis greater than Grade 2 (Mild)
- •Anterior uveitis or iritis (past or present)
- •Known sensitivity to the care systems used in this study.
- •Poor personal hygiene
- •Current pregnancy or is lactating (to the best of the subject's knowledge) or subject is planning pregnancy within the next 13 months.
- •Any active participation in another clinical study within 30 days prior to this study.
- •Subject is a member, relative or household member of the office staff, including the investigator(s).
- •Subjects must read, indicate understanding of, and sign the Informed Consent Form.
结局指标
主要结局
Frequency of serious and significant AEs
时间窗: 1 Year
Frequency of serious and significant AEs defined as a composite of infiltrates of higher than grade 2 and/or infiltrates with any overlying staining, peripheral ulcer, and loss of two or more lines of visual acuity at any time during the trial
次要结局
- Contact Lens Visual Acuity(1 Year)
研究者
研究点 (42)
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