NCT01735045已完成3 期
LSH Silicone Hydrogel Soft Hydrophilic Contact Lens for Daily Wear
Szabocsik and Associates, Inc.5 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2010年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 5
- 主要终点
- Visual Acuity
研究概览
简要总结
This study is to evaluate the performance of the LSH (mangofilcon A) silicone hydrogel soft contact lenses when used as a daily wear contact lens for the correction of myopia.
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
- 是
入选标准
- •Have been advised that the contact lenses they will be wearing for the next 3 months are being used for investigational purposes and that their informed consent will be needed and documented prior to the start of the study.
- •Visual acuity must be correctable to 20/30, with spherical lenses ranging in power from -1.00 to -5.00D, astigmatism≤1.50D.
- •Have been successfully wearing soft (hydrophilic) contact lenses for at least one month prior to entering the study. (Success means both subject and practitioner are satisfied with visual acuity, comfort, and ocular physiology).
- •Have non-diseased eyes which are normal or which have no preexisting ocular condition which would interfere with the patient's ability to adapt to the new pair of LSH Silicone Hydrogel Soft (hydrophilic) Contact Lenses. A normal eye is defined as one having all the following characteristics:
- •No evidence of lid infection.
- •No structural lid abnormality.
- •No conjunctival abnormality or infection.
- •A cornea which is clear with no edema, staining, vascularization or abnormal opacities, all as observed by slit lamp examination.
- •No other active ocular disease that would contraindicate use of the investigational lens.
- •No GPC (giant papillary conjunctivitis, tarsal abnormality) Grade 2 or greater
- •Use no ocular medication.
- •Have no known sensitivity to solutions currently used for contact lens care.
- •Have binocular correction with contact lenses.
排除标准
- •Astigmatism >1.50D
- •No monocular or monovision fits may be included.
- •Pregnant and lactating women are excluded from the study
- •Minors (under age 18) are excluded from the study
研究组 & 干预措施
Test Group myopia control
Experimental
Subjects wearing contact lenses made of LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for myopia control
干预措施: Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens (Device)
Myopia Control
Active Comparator
Subjects wearing Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens for myopia control
干预措施: Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens (Device)
结局指标
主要结局
Visual Acuity
时间窗: 3 months
Snelling Scale
次要结局
- Slit Lamp Findings(3 months)
研究者
研究点 (5)
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