EUCTR2018-001077-24-NL进行中（未招募）1 期
CHAMP: A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children with Myopia - CHAMP
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Vyluma Inc.
- 入组人数
- 483
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Children (male or female) aged 3 to = 17.0 years.
- •2. Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.
- •6. Distance vision correctable to at least 0.1 logMAR or 20/25 Snellen
- •equivalent in each eye.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 483
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. If present, astigmatism more than -1.50 in either eye
- •2. Current or history of amblyopia or manifest strabismus.
- •3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- •4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
- •5. Serious systemic illness that, in the Investigator’s opinion, would render the subject ineligible.
- •6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over-the-counter) other than the assigned study medication.
- •19. Current or history of significant or severe damage to the cornea.
研究者
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