NCT03329638已完成2 期
A Phase II, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group Study Assessing the Efficacy and Safety of DE-127 Ophthalmic Solution Compared With Placebo in Subjects With Mild or Moderate Myopia (APPLE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Spherical equivalent
研究概览
简要总结
To investigate the safety and efficacy of three concentrations of DE-127 ophthalmic solution when compared to Placebo in subjects diagnosed with mild or moderate myopia.
To investigate the dose response of DE-127.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Refractive error of spherical equivalent -1.0 diopter to -6.0 diopter in both eyes
- •Anisometropia of spherical equivalent less than or equal to 1.50 diopter in both eyes
- •Distance vision correctable to logMAR 0.2 or better in both eyes
- •Normal intraocular pressure of not greater than 21 mmHg in both eyes
- •No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride
排除标准
- •Amblyopia or manifest strabismus including intermittent tropia
- •Ocular disorders that potentially affect myopia or refractive power
- •Previous or current use of contact lenses, bifocal lenses, progressive addition lenses, or other forms of treatment (including atropine and pirenzepine) for myopia
- •Systemic disorders that potentially affect myopia or refractive power
研究组 & 干预措施
DE-127 Ophthalmic Solution low dose
Experimental
干预措施: DE-127 Ophthalmic Solution low dose (Drug)
DE-127 Ophthalmic Solution medium dose
Experimental
干预措施: DE-127 Ophthalmic Solution medium dose (Drug)
DE-127 Ophthalmic Solution high dose
Experimental
干预措施: DE-127 Ophthalmic Solution high dose (Drug)
Placebo Ophthalmic Solution
Placebo Comparator
干预措施: Placebo Ophthalmic Solution (Drug)
结局指标
主要结局
Spherical equivalent
时间窗: Month 12
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at Month 12 in the study eye.
次要结局
未报告次要终点
研究者
研究点 (1)
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