Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
研究概览
简要总结
This study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. All subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. The study has a total of 9 scheduled study visits and a total duration of ~197 days. The lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.
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
- Double (Participant, Investigator)
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
- •The subject must read and understand English 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 at least 18 and no more than 39 years of age.
- •The subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye.
- •The subject's refractive cylinder must be less than 1.00 diopters in each eye.
- •The subject must have best corrected visual acuity of 20/30 or better in each eye.
- •The subject must be without history of contact lens use in the past 12 months.
- •The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
- •Currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued).
- •Currently a regular smoker (1 or more times per month).
- •Current routine swimmer (1 or more times per month).
- •Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •Any systemic disease (ex. Sjögren's Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), 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 by keratometry.
- •Any previous or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (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 that 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 product clinical trial within 7 days prior to study enrollment.
- •History of binocular vision abnormality or strabismus.
- •Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report).
- •Employee of investigational clinic (e.g., Investigator, Coordinator, Technician).
研究组 & 干预措施
etafilcon A (1-Day) and etafilcon A (Reusable)
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: etafilcon A (Reusable) (Device)
etafilcon A (1-Day) and etafilcon A (Reusable)
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: etafilcon A (1-Day) (Device)
etafilcon A (1-Day) and Investigational Lens 1
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: Investigational Lens 1 (Device)
etafilcon A (1-Day) and Investigational Lens 1
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: etafilcon A (1-Day) (Device)
etafilcon A (1-Day) and Investigational Lens 2
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: Investigational Lens 2 (Device)
etafilcon A (1-Day) and Investigational Lens 2
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: etafilcon A (1-Day) (Device)
etafilcon A (1-Day) and Investigational Lens 3
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: Investigational Lens 3 (Device)
etafilcon A (1-Day) and Investigational Lens 3
Prior to randomization, all subjects will participate in a 2-week contact lens adaptation period wearing etafilcon A (1-Day). Subjects will then be randomized to one of four experimental contact lenses to be worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
干预措施: etafilcon A (1-Day) (Device)
结局指标
主要结局
Number of First Occurred Serious and Significant Lens-related Corneal Infiltrative Event (CIE)
时间窗: Up to 6 months
The number of first serious and significant corneal infiltrative adverse events deemed to be related to contact lens wear (possible, probable or very likely) during a 6-month period (contact lens extended wear period) was assessed via Biomicroscopy. A biomicroscope was used to detect the presence of a corneal infiltrate for each subject eye (Yes: corneal infiltrates detected, No: None present). The number of subjects with corneal infiltrative events was reported for each lens type.
次要结局
- Overall Comfort Score(Time Frame Up to 6 months)
- Overall Vision Score(Time Frame Up to 6 months)