jRCT2052240055进行中（未招募）不适用
Clinical trial for the safety and efficacy of MEL-01 soft contact lens
SEED Co., Ltd.0 个研究点目标入组 63 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 63
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Refractive error (spherical equivalent: -1.00D to -7.00D)
- •(2) Astigmatism power: -1.50D or less
- •(3) Best corrected visual acuity with spectacles: 1.0 or better in each eye
- •(4) Patients who are able to participate in scheduled visits
- •(5) Patients who habitually wear soft contact lenses
- •(6) Age 18 or older at the time of consent acquisition *Gender does not matter
- •(7) Understood the content of the trial and be able to give written informed consent by their freewill
排除标准
- •(1) Patients with moderate or higher corneal, conjunctival, or eyelid findings (findings of * or higher in the slit-lamp microscopy evaluation criteria table are considered moderate or higher findings)
- •(2) Patients with uveitis
- •(3) Patients with dry eye and lacrimal disorders that cause problems with lens wearing
- •(4) Patients with allergic disease to a degree that affects lens wearing
- •(5) Patients with diabetes
- •(6) Patients with a history of anaphylaxis
- •(7) Patients with complications considered unsuitable for the clinical trial; such as serious heart, liver, kidney, lungs, blood disorders, etc.
- •(8) Patients who have participated in other clinical trials (including all areas) within the past 3 months and received (used) investigational drugs or are currently participating in another clinical trial within the past 3 months, or patients who are planning to participate in another clinical trial during the course of this trial.
- •(9) Pregnant or lactating women or patients who may be pregnant, patients who wish to become pregnant from the time of consent to the end of clinical trials, patients who do not consent to contraception from the time of consent to the end of the clinical trials
- •(10) Patients who are always in a dry environment (such as working in refrigerated warehouses)
- •(11) Patients in an environment where dust and chemicals can easily get into the eyes (workers in places with a lot of dust such as ironworks and road construction, and people who handle chemicals in experiments, etc. However, those who are working with safety glasses (goggles) are excluded. )
- •(12) Patients who habitually wear RGP lenses
- •(13) Patients with a history of refractive surgery
- •(14) Patients with experience wearing orthokeratology lenses
- •(15) Patients using monovision correction or patients who wear contact lenses for only one eye
- •(16) Patients who are judged by the investigator or subinvestigator to be ineligible for the study, or who are judged by the investigator or subinvestigator to be inadequate for wearing this investigational device due to poor fitting, etc.
结局指标
主要结局
-
Total incidence rate of lens discontinuation
次要结局
未报告次要终点
研究者
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