A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Vyluma, Inc.
- 入组人数
- 670
- 试验地点
- 26
- 主要终点
- Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit
研究概览
简要总结
Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period.
Stage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive myopia.
详细描述
This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.
Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.
Stage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002.
Treatment arms are:
- NVK-002 low dose concentration
- NVK-002 high dose concentration
- Vehicle (placebo)
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)
盲法说明
If subjects meet eligibility criteria at the Screening/Baseline visit (Day 0), subjects will be randomly assigned to masked study medication.
The study will be double masked. The study medication will be provided in identical-appearing laminated pouches with no labeling indicating the identity of the study group or the contents of the ampules. The laminated pouches will contain identical-appearing ampules. Study subjects and study management personnel will be masked to the identity of treatment until after the final database lock.
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to ≤ 17.0 years.
- •Myopia SER of at least -0.50 D and no worse than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.
排除标准
- •If present, astigmatism more than -1.50 D in either eye.
- •Current or history of amblyopia or strabismus.
- •History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- •History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
- •Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
- •Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.
研究组 & 干预措施
NVK-002 Concentration 1
Stage 1: Subjects will be randomized to NVK-002 Concentration 1
Stage 2: Subjects will be re-randomized to one of the three treatment arms.
干预措施: NVK-002 Concentration 1 (Drug)
NVK-002 Concentration 2
Stage 1: Subjects will be randomized to NVK-002 Concentration 2
Stage 2: Subjects will be re-randomized to one of the three treatment arms.
干预措施: NVK-002 Concentration 2 (Drug)
Vehicle (Placebo)
Stage 1: Subjects will be randomized to Vehicle (Placebo)
Stage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit
时间窗: 36 Months
Number of subjects' eyes that show \< 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.
次要结局
- Change From Baseline in SER (Spherical Equivalent Refraction)(Month 36)