The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Progression of Myopia in Children and Adolescents in a Randomized, Double-blind, Placebo Parallel-controlled, Multicenter, Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 606
- 试验地点
- 25
- 主要终点
- Effective change from baseline in equivalent spherical refraction at Week 96 visit
研究概览
简要总结
The clinical trial aims to test the effectiveness and safety of two low-dose atropine sulfate eye drops for delaying myopia progression in children and adolescents.
Primary Objective: evaluate the effectiveness of 0.01% and 0.02% atropine sulfate eye drops for 96 weeks compared to placebo in delaying myopia progression in children and adolescents. Secondary Objective: evaluate the safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) in delaying myopia progression in children and adolescents.
Exploratory Objective:
- the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks.
- evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking aims to achieve the unpredictability of randomized treatment groups by all parties involved in a clinical trial. To reduce the influence of evaluation bias or other factors, a double-blind experimental design was adopted in this study. Placebo is the auxiliary ingredient of atropine sulfate eye drops, and its specification, color, smell, etc. are consistent with the test drug and do not contain the active ingredient of the test drug. The drug in the experimental group was packaged in the same packaging as the placebo, and blinded according to random numbers to ensure that both the investigator and the subject were masked.
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
- •The legal guardian of the subject voluntarily signed the written informed consent, and the subject over 8 years is required to sign the written informed consent voluntarily.
- •Patients with myopia aged 6 to 12 years, including cut-offs.
- •The equivalent spherical refraction ranges from -1.00 D to -4.00 D (automatic optometry under a cycloplegia condition) in both myopia eyes at inclusion screening.
- •The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
- •The antimetropia (measured by equivalent spherical refraction) is < 2.00 D at inclusion screening.
- •Able to comply with study requirements, attend all study visits (including telephone visits), and be willing to receive random grouping of atropine treatment or placebo.
排除标准
- •Allergic to this product or its excipients.
- •Suffering from eye diseases that may affect vision (e.g. lens diseases such as cataracts, glaucoma, fundus macular disease, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc., manifest strabismus, nystagmus, ocular acute inflammatory disease), history of recurrent chronic ocular inflammation, or any other ocular pathology (e.g., angular stenosis, shallow anterior chamber).
- •Intraocular pressure of either eye is > 21 mmHg or <10 mmHg at screening.
- •Use of low-concentration (0.05% and below) atropine sulfate eye drops (including various in-hospital preparations, except for test drugs) and orthokeratology lenses (OK lenses) within 6 months before the screening.
- •Use of other myopia control methods such as instruments (multifocal glasses, progressive multifocal glasses, etc.), medications (the use of cycloplegic agents for examinations such as optometry is allowed), and others (including traditional Chinese medicine, auricular acupuncture, massage, accommodative flippers, red light therapy instrument, etc.) within 3 months before screening.
- •Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
- •Systemic or topical use of drugs that affect the efficacy evaluation, such as anticholinergics: atropine, pirenzepine, etc., and cholinomimetics: pilocarpine, etc. within 1 week before screening.
- •Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
- •Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
- •Heart rate sustained (more than 10 minutes) greater than 120 beats/min at screening (after 10 minutes of rest if the ECG shows a heart rate greater than 120 beats per minute, the ECG should be retested 10 minutes later. If the retest result below 120 beats/min, the screening is successful; If the retest result is still >120 beats/min, screening failed).
- •Need for ocular use or systemic oral corticosteroids during the study. Intranasal, inhaled, topical cutaneous, intra-articular, perianal steroids, and short-term oral steroids (i.e., continuous use for < 2 weeks).
- •Other conditions that are considered unsuitable by the investigator.
研究组 & 干预措施
Experimental group (0.01% atropine sulfate eye drops)
1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
干预措施: Atropine sulfate eye drops 0.01% (Drug)
Experimental group (0.02% atropine sulfate eye drops)
1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
干预措施: Atropine sulfate eye drops 0.02% (Drug)
Control group (placebo eye drops)
1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
干预措施: Placebo eye drops (Drug)
结局指标
主要结局
Effective change from baseline in equivalent spherical refraction at Week 96 visit
时间窗: At the Week 96 visit
The inter-group difference in the value of change from baseline in equivalent spherical refraction after 0.01% or 0.02% atropine sulfate eye drops versus placebo under a cycloplegia condition at the Week 96 visit
次要结局
- Effective change from baseline in eye axis length at 24 months(At the Week 96 visit)
- Progression of refraction ≤0.75D at 12 months and 24 months and percentage(At the Week 48 and Week 96 visits)
- Effective change from baseline in refraction at 12 months(At the Week 48 visit)
- Effective change from baseline in ocular axis length at 12 months(At the Week 48 visit)
- Progression of refraction ≤0.50 D at 12 months and 24 months and percentage(At the Week 48 and Week 96 visits)
- Progression of refraction ≤1.00D at 12 months and 24 months and percentage(At the Week 48 and Week 96 visits)
- Progression of refraction >1.00D at 12 months and 24 months and percentage(At the Week 48 and Week 96 visits)
- Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months(At the Week 48 and Week 96 visits)
- Change from baseline in other ocular morphologic measures at 12 months and 24 months(At the Week 48 and Week 96 visits)