A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Different Concentrations of QLM3004 in Delaying the Progression of Myopia in Children
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 735
- 试验地点
- 1
- 主要终点
- Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.
研究概览
简要总结
Efficacy and Safety Study of QLM3004 in Myopic Children
详细描述
The study was divided into 2 phases, with Stage 1 being the primary efficacy and safety confirmation phase and Stage 2 a post-withdrawal observation period.
Stage 1:To evaluate the safety and efficacy of 3 concentrations of QLM3004 compared to Vehicle (placebo)for slowing the progression of myopia in children over a 96-week treatment period.
Stage 2:subjects will enter Period 2 of the study, and Period 2 will be a post-withdrawal observation period, which will not serve as a validation basis for the efficacy and safety of QLM3004.
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 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6 to 12 years
- •Myopia -1.00D to -4.00D spherical equivalent (SE) in both eyes as measured by cycloplegic autorefraction.
- •Astigmatism ≤1.50 D in both eyes.
- •Anisometropia ≤1.50 D SE.
- •Informed consent signed by the subjects and/or their legal representatives
排除标准
- •Suffering from serious systemic diseases
- •Any eye disease that affect vision or refractive error
- •Current or prior history of manifest strabismus, amblyopia, or other ocular pathologic changes
- •Acute inflammatory disease or active infection of the eye in either eye, or a history of chronic ocular inflammation or recurrent episodes of ocular inflammation
- •Best corrected distance visual acuity in both eyes<4.9
- •Abnormal intra-ocular pressure (>21 mmHg or difference between two eyes >5mmHg)
- •Current or previous form of myopia control, including but not limited to drugs, orthokeratology, progressive addition lenses, bifocal lenses, etc.
- •Systemic or topical use of medications within 3 months that interfere with efficacy evaluation (excluding optometry)
- •Allergy or hypersensitivity to atropine, excipients, cyclopentolate or fluorescein sodium
- •Participants for whom the clinical significance of ophthalmologic examination abnormalities indicate that one or both eyes are not suitable candidates for treatment based upon the Investigator's medical judgment
- •Participation of the drug clinical trial within three month and the device clinical trial within one month
- •Anticipated long-term use of ocular or systemic oral corticosteroids during the study period
- •Any other condition not suitable for the study per investigator's judgement
研究组 & 干预措施
QLM3004 Concentration 1
Solution low dose
干预措施: QLM3004 Concentration 1 (Drug)
QLM3004 Concentration 2
Solution medium dose
干预措施: QLM3004 Concentration 2 (Drug)
QLM3004 Concentration 3
Solution high dose
干预措施: QLM3004 Concentration 3 (Drug)
Placebo
Placebo Ophthalmic Solution
干预措施: Placebo (Other)
结局指标
主要结局
Change from Baseline in spherical equivalent determined by cycloplegic autorefraction at week 96.
时间窗: 96 week
Effectiveness Evaluation
次要结局
未报告次要终点