NCT06616519已完成不适用
Multi-center, Open, Parallel, and Randomly Controlled Comparison Between MSENC1 Soft Hydrophilic Contact Lenses and Oxypure Color Soft Hydrophilic Contact Lenses in Their Safety and Efficacy
BenQ Materials Corporation2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2021年5月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- efficacy evaluation indexes
研究概览
简要总结
This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of MSENCI soft hydrophilic contact lenses with Oxypure color soft hydrophilic contact lenses used as the control product.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, no gender limitation;
- •Soft hydrophilic contact lenses worn should be from 0.00D to -12.00D;
- •Subjects should have normal binocular conditions without any abnormality or diseases except for ametropia;
- •The optimal binocular CVA with glasses ≥ 1.0;
- •The astigmatism should be ≤1.5D;
- •Binoculus BUT >5s;
- •should accept follow-ups for at least 90 days and wear the contact lens as required in the protocol;
- •should understand the purpose of the trial, volunteer to attend and sign the Informed Consent Form by the subjects themselves or their legal guardians.
排除标准
- •Patients who suffer from systemic diseases that prohibit contact lens use or receive treatment that may affect the vision or contact lens use;
- •Patients who have worn hard contact lenses within 4 weeks or soft contact lenses within 7 days before being included in the trial;
- •Patients who are allergic to contact lenses or suffer from systemic allergy;
- •Patients who have keratoconus or other cornea irregularity;
- •Patients who always stay at places that are dry, dust-heavy, having volatile chemicals or otherwise affect the use of soft hydrophilic contact lenses;
- •People who are pregnant, during their lactation or prepare for the pregnancy while being included;
- •People who have only a single eye qualified for the trial;
- •People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
- •People who have attended a clinical trial of medicine or medical devices other than contact lens within 3 months before being included in this trial;
- •Other cases where investigators determine the soft contact lens should not be used or the candidate should be excluded.
结局指标
主要结局
efficacy evaluation indexes
时间窗: after wearing lenses for 7 days
Binocular CVA with lenses after wearing lenses, The percentage of changes in iris color
次要结局
- Time of Break up time (BUT)(on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days)
- Distance Uncorrected visual acuity (UCVA)(on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days)
- Fitness of the contact(on the day of wearing the lens and wearing lenses for 7 days,30 days and 90 days)
研究者
研究点 (2)
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