JPRN-jRCTs052180004已完成未知
Clinical study of 1day disposable silicone hydrogel lens Myday - Clinical study of 1day disposable silicone hydrogel lens Myday
Kodama Yuji0 个研究点目标入组 50 人开始时间: 2018年8月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
Overall fitting assessment of the Test lens(T)at the time of dispensing was Favorable(F)in 82 Eyes(E),Generally favorable(G)in 16E,and Wearable(W)in 2E.That of the Control lens(C)was F in 61E,G 29E,and W in10E.The fitting was statisically significantly favorable with the T.The assessment of the T after 1-week usage was F in 83E,G in 10E,and W in 7E.That of the control lens was F in 60E,G in 28E,and W in12E.Fitting was statistically significantly F with the T-wearing eye.T was generally superior in fitting.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 42age old（—）
- 性别
- All
入选标准
- •1.Individuals who are between 18 and 42 years old at the time of consent. However, for individuals under the age of 20, in addition to their informed consent, a written consent should be obtained from a parent or legal guardian.
- •2.Individuals who are wearing one day disposable SCL except My Day and One Day Acuvue True Eye in both eyes for longer than 8 hours a day and more than 5 days a week.
- •3.Individuals having 0.75 D or less astigmatism obtained by subjective refraction and no symptoms of presbyopia.
- •4.Individuals who wear SCL within the power range of the study CL (-2.00 to -7.00D).
- •5.Individuals with distant visual acuity equal to 1.0 or better for each eye, when corrected with spherical and cylindrical lenses.
- •6.Individuals who are able to read and understand the instruction of this study and provide signed informed consent.
- •7.Individuals who can visit the clinic as scheduled.
- •8.Individuals who have had eye examination at the eye clinic within the last two years.
- •9.Individuals who can limit wearing time between 8 hours and 16 hours per day.
- •10.Individuals with clear cornea and no active ocular disease.
排除标准
- •1.Individuals with any systemic disease affecting ocular health.
- •2.Individuals who are pregnant or in the lactation period.
- •3.Individuals who are using any systemic or topical medications which could affect the result of the study.
- •4.Individual with infectious eye disease.
- •5.Individuals who have ocular or systemic allergy disease which could prevent from wearing SCL.
- •6.Individual who have medium to severe dry eye symptoms which could affect SCL wear.
- •7.Individuals who have clinically severe eye disease such as neovascularization, limbal hyperemia and corneal epithelial defects.
- •8.Individuals who have clinically severe disorder in the eyelid or conjunctiva.
- •9.Individuals with an aphakia or an intraocular lens.
- •10.Individuals who have worn Hard Contact Lenses within 30 days.
- •11.Individuals working in the clinic or the family members who are subject to conflict of interest with the following companies related to this study.
- •- Cooper Vision Japan, Inc
- •- Six Bleu Co., Ltd
- •- Ai Research, Inc
- •- Johnson & Johnson, Inc
- •12.Individuals who are participating in other clinical study.
- •13.Individuals who have had corneal refractive surgery.
研究者
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