Acceptance & Tolerance Study of Multifocal Contact Lenses by Functional Emmetropes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 4
- 主要终点
- Proportion of Successful Contact Lens Wearers
研究概览
简要总结
The primary objective of this study is to determine the retention rate over a two month period of vision correction in emmetropic, presbyopes fitted with multifocal contact lenses.
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
- 40 Years 至 70 Years（Adult, Older 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 between 40 and 70 years of age.
- •The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to +2.00 in each eye.
- •The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
- •The subject's ADD power must be in the range of +0.75 D to +2.
- •The subject must have best corrected visual acuity of 20/25 or better in each eye.
排除标准
- •Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •Any ocular or systemic allergies that contraindicate contact lens wear.
- •Any ocular or systemic disease, autoimmune disease, or use of medication, that contraindicates contact lens wear.
- •Any ocular abnormality that may interfere with contact lens wear.
- •Use of any ocular medication, with the exception of rewetting drops.
- •Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- •Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- •History of herpetic keratitis.
- •Any ocular infection or inflammation.
- •Any corneal distortion or irregular cornea.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
- •History of diabetes.
- •Current or previous history of being prescribed a correction for distance vision.
- •Current or previous history of contact lens wear.
- •Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
研究组 & 干预措施
Multifocal Test Contact Lens
Subjects will wear the test lenses at least six hours per day, at least five days per week
干预措施: Multifocal Test Contact lens (Device)
结局指标
主要结局
Proportion of Successful Contact Lens Wearers
时间窗: 2 months post wear
Proportion of Successful contact lens wearers is based on a subject's responses to two questionnaire items, "Overall Quality of Vision" and "Overall Comfort". Each item uses a 6 response like-rt scale (0= Not Applicable, 1=Excellent, 2=Very Good, 3=Good, 4=Fair and 5=Poor). The data from each item was dichotomized into two groups. If a subject responded "Excellent", "Very Good" or "Good" then the response=1, otherwise the response=0. The proportion of subjects with response=1 was reported as the proportion of successful contact lens wearers.
次要结局
未报告次要终点