CTRI/2015/04/005701已完成2 期
Echo Ionic Silicone Hydrogel 6-Month Extended Wear Investigation - NI
Johnson and Johnson Vision Care Inc0 个研究点目标入组 280 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •A. The subject must read and understand English and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- •B. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- •C. The subject must be at least 18 and no more than 39 years of age.
- •D. The subjectâ??s spherical equivalent distance refraction must be in the range of -1.00 to - 5.50 diopters in each eye.
- •E. The subjectâ??s refractive cylinder must be less than 1.00 diopters in each eye.
- •F. The subject must have best corrected visual acuity of 20/30 or better in each eye.
- •G. The subject must be without history of contact lens use in the past 12 months.
- •H. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
排除标准
- •A. Any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month)
- •B. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- •C. Currently a regular smoker (1 or more times per month).
- •D. Current routine swimmer (1 or more times per month).
- •E. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- •F. Any systemic disease (ex. Sjögrenâ??s Syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), which may interfere with contact lens wear.
- •G. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- •H. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy,PRK, LASIK, etc.).
- •I. 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 cornealinflammatory event (e.g., past peripheral ulcer or round peripheral scar), or anyother ocular abnormality that may contraindicate contact lens wear.
- •J. Any ocular infection.
- •K. Any corneal distortion resulting from previous hard or rigid gas permeable contactlens wear.
- •L. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
- •M. History of binocular vision abnormality or strabismus.
- •N. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self report).
- •O. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
研究者
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