NCT01990664已完成不适用
A Multi-Center Clinical Evaluation of Lapsed Contact Lens Wearers Who Are Re-Fit Into Spherical or Toric Senofilcon A Contact Lenses
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
- 199
- 试验地点
- 10
- 主要终点
- Proportion of Successfully Re-fitted Subjects
研究概览
简要总结
This study is an open-label, multi-site study. The total number of subjects was 200. The duration of this study was approximately four weeks. The primary objective was to assess what percentage of lapsed contact wearers, who have discontinued use of their contact lenses for greater than six months can be successfully re-fit with senofilcon A, reusable 2-weekly replacement daily wear lenses (spherical and toric designs).
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject must read, understand , and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- •The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •The subject must be interested in wearing contact lenses.
- •The subject must be at least 18 years old or less than 40 years of age at the time of consent.
- •The subject's vertexed spherical cylindrical refraction must result in a contact lens prescription for each eye that is available in the investigator's choice of study contact lens material(s).
- •The subject must have best corrected visual acuity of 20/30 or better in each eye.
- •The subject must require visual correction in both eyes.
- •The subject must be a lapsed wearer (defined as, any non-contact lens wearer requiring optical correction who has been previously fitted in and has previously purchased contact lenses but has since discontinued contact lens wear for any reason more than 6 months prior to the time of consent).
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- •Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion.
- •Any previous, or planned, ocular or intraocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), LASIK, etc.)
- •Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality tha may contraindicate contact lens wear.
- •Any ocular infection.
- •Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- •Participation in any contact lens or lens care trial within one year prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g., HIV), by self report.
- •Employee of the investigational clinic (i.e., Investigator, Coordinator, or Technician).
研究组 & 干预措施
senofilcon A
Experimental
Contact lenses to be worn in a daily wear modality
干预措施: senofilcon A (Device)
senofilcon A for Astigmatism
Experimental
Contact lenses to be worn in a daily wear modality
干预措施: senofilcon A for Astigmatism (Device)
结局指标
主要结局
Proportion of Successfully Re-fitted Subjects
时间窗: 4 weeks
Percentage of lapsed contact wearers who were successfully refitted among subjects who have lapsed from contact lens use more than 6 months prior to the date of enrollment in the study. Successful fit was assessed by on eye care practitioner (ECP) judgment of acceptable physiology.
次要结局
未报告次要终点
研究者
研究点 (10)
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