NCT06716385已完成不适用
A Prospective, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate the Vision Correction Safety and Efficacy of MSiHy Silicone Hydrogel Soft Contact Lens
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 3
- 主要终点
- Visual Correction
研究概览
简要总结
This is a prospective, randomized, double-blind, parallel, active-controlled, multi-center clinical study. The purpose is to evaluate the safety and effectiveness wearing "MSiHy Silicone Hydrogel Soft Contact Lens".
Subjects will be randomized in 1:1 ratio to wear either the investigational device "MSiHy Silicone Hydrogel Soft Contact Lens" or the control device Monthly Silicone Hydrogel Contact Lenses(oA)".
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Must be 18 years of age inclusive
- •Beside myopia and astigmatism, subjects with normal eyes and are not using any ocular medications (excluding ocular lubricants and artificial tears)
- •Best spectacle corrected visual acuity greater than or equal to 1.0 for both eyes
- •With +8.00D ~ -12.00 D spherical component myopia, and ≤1.00 astigmatism (based on manifest refraction measurements)
- •Have worn soft contact lens for at least 2 month prior to the study
- •Willing to comply with the required wearing time
- •Agree to comply with all study procedures, sign and date the informed consent form before starting the clinical study
排除标准
- •Anterior segment infection, inflammation or abnormality
- •Any active ocular disease that would affect contact lens wear or vision (such as acute and subacute inflammation of the anterior chamber of the eye, eye infection, uveitis, serious palpebral abnormality, corneal hypoesthesia, corneal epithelium abrasion, dry eye and tear duct defection, ocular allergies, highly suspected glaucoma) upon evaluation by the investigators or slit lamp findings
- •Currently using systemic or ocular medications that would contraindicate contact lens wear (such as glaucoma eye drops, steroid anti-inflammatory drops, eye ointments, eye gels and other eye medicines)
- •History of herpetic keratitis
- •History of refractive surgery, keratoconus or irregular cornea
- •Slit lamp findings that are not suitable for inclusion (Details of the grading standards for each eye condition are specified in CIP section 5.7.5)
- •A pathologically dry eye (Schirmer test 1 <5 mm)
- •Have participated in any contact lens or contact lens care product clinical trials within the previous 1 month (excluding questionnaire types and specimen collection)
- •Currently pregnant, lactating, or planning to be pregnant during the trial
- •Have experienced discomfort when wearing silicone hydrogel contact lens, or a known allergy to hyaluronic acid and sodium alginate
- •Allergy to any contact lens care product ingredient
- •Corrected visual acuity in either eye does not reach 1.0 when wearing the trial lens
- •Subjects who are judged by the investigators as unsuitable for the study
研究组 & 干预措施
MSiHy Silicone Hydrogel Soft Contact Lens
Experimental
New Monthly disposable contact lenses
干预措施: MSiHy Silicone Hydrogel Soft Contact Lens (Device)
Monthly Silicone Hydrogel Contact Lenses (oA)
Active Comparator
Monthly disposable contact lens products already on the market
干预措施: Monthly Silicone Hydrogel Contact Lenses (oA) (Device)
结局指标
主要结局
Visual Correction
时间窗: 3 months
The effectiveness of vision correction is defined by the proportion of subjects whose contact lens corrected visual acuity in both eyes is 1.0 or greater.
次要结局
- Visual Correction(1 week, 2 week, 1 month and 2 months)
- Change in refraction(1 week, 2 week, 1 month, 2 months and 3 months)
研究者
研究点 (3)
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