NCT02345720已完成不适用
Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study
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
- 23
- 试验地点
- 1
- 主要终点
- Limbal Staining
研究概览
简要总结
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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 too -5.75 in each eye.
- •The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
- •The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
- •The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
- •The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- •Subjects own a wearable pair of spectacles, if required for their distance vision.
- •The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).
- •The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
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 will contraindicate contact lens wear.
- •Any ocular abnormality that may interfere with contact lens wear.
- •Use of any ocular medications, 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.
- •Habitual wearer of etafilcon-A contact lens material.
- •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
etafilcon - PVP (multi-focal)
Experimental
The investigational soft contact lenses will be worn in a daily wear modality for 30 days over the course of the study.
干预措施: etafilcon - PVP (multi-focal) (Device)
结局指标
主要结局
Limbal Staining
时间窗: 30 Days Post Wear
Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
Corneal Staining
时间窗: 30 Days Post Wear
The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
Upper Eye Lid Margin Staining
时间窗: 30 days Post wear
Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm\^2.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide ImplantInflammationUveitisNCT01060787Bausch & Lomb Incorporated98
招募中
2 期
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative VitreoretinopathyProliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentNCT05523869Unity Health Toronto50
已完成
不适用
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing TechnologyVisual AcuityNCT03962790Johnson & Johnson Vision Care, Inc.95
终止
不适用
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding ProcessRefractive Error CorrectionNCT03605303Johnson & Johnson Vision Care, Inc.3
已完成
不适用
Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Molding Process 2MyopiaNCT03701516Johnson & Johnson Vision Care, Inc.268