NCT03742271已完成不适用
Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 11
- 主要终点
- Acceptable Lens Fitting
研究概览
简要总结
This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.
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
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Potential subjects must satisfy all of the following criteria to be enrolled in the study:
- •The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •Between 18 and 39 (inclusive) years of age at the time of screening.
- •They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
- •Habitual spectacles must have resulted from an eye exam within the past six months.
- •The subject must have worn the updated spectacles for at least two weeks.
- •Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
- •The subject's refractive cylinder must be -1.00 D or less in each eye.
- •Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or better in each eye.
排除标准
- •Potential subjects who meet any of the following criteria will be excluded from participating
- •Currently pregnant or lactating.
- •Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
- •Use of systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).
- •Any current use of ocular medication.
- •Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.
- •Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
- •Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
- •Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
- •Any Grade 3 or 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.
- •Binocular vision abnormality or strabismus.
研究组 & 干预措施
senofilcon A
Experimental
Subjects that are habitual spectacle wearers that have never worn contact lenses and have had an eye exam and an updated spectacle prescription in the last 6 months will be enrolled and fitted into the senofilcon A TEST Lens for a total period of 4 weeks.
干预措施: senofilcon A (Device)
结局指标
主要结局
Acceptable Lens Fitting
时间窗: 4-Week Follow-up
Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.
次要结局
未报告次要终点
研究者
研究点 (11)
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