Clinical trial NCT06708156: The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Myopia
Myopia Progression
Keywords: Myopia
Atropine
Lead sponsor: Oupushifang Pharmaceutical Technology Co., Ltd.
Sponsor class: OTHER
Collaborators: name: Seefunge Pharmaceutical Technology Co., Ltd.
name: AUTEK China Inc.
First posted: 2024-11-27
Enrollment: 606
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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:

1. the efficacy and safety of two low-concentration atropine sulfate eye drops (0.01%/0.02%) for 144 weeks.
2. evaluate the rebound effect of two low-concentration atropine sulfate eye drops (0.01%/0.02%) after discontinuation.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patients with myopia aged 6 to 12 years, including cut-offs.
3. 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.
4. The astigmatism of both eyes was ≤ 1.50 D under a cycloplegia condition at inclusion screening.
5. The antimetropia (measured by equivalent spherical refraction) is \< 2.00 D at inclusion screening.
6. 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.

Exclusion Criteria:

1. Allergic to this product or its excipients.
2. 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).
3. Intraocular pressure of either eye is \> 21 mmHg or \<10 mmHg at screening.
4. 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.
5. 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.
6. Those who have participated in other clinical trials and received drug or medical device interventions within 3 months before screening.
7. 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.
8. Combined with severe immune system disease, central nervous system disease, Down syndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.
9. Surgical intervention (ocular or systemic) within 6 months before screening, or planned surgery during the study.
10. 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).
11. 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).
12. Other conditions that are considered unsuitable by the investigator.

Primary outcomes:
measure: Effective change from baseline in equivalent spherical refraction at Week 96 visit
timeFrame: At the Week 96 visit
Secondary outcomes:
measure: Effective change from baseline in eye axis length at 24 months
timeFrame: At the Week 96 visit
measure: Effective change from baseline in refraction at 12 months
timeFrame: At the Week 48 visit
measure: Effective change from baseline in ocular axis length at 12 months
timeFrame: At the Week 48 visit
measure: Progression of refraction ≤0.50 D at 12 months and 24 months and percentage
timeFrame: At the Week 48 and Week 96 visits
measure: Progression of refraction ≤0.75D at 12 months and 24 months and percentage
timeFrame: At the Week 48 and Week 96 visits
measure: Progression of refraction ≤1.00D at 12 months and 24 months and percentage
timeFrame: At the Week 48 and Week 96 visits
measure: Progression of refraction >1.00D at 12 months and 24 months and percentage
timeFrame: At the Week 48 and Week 96 visits
measure: Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months
timeFrame: At the Week 48 and Week 96 visits
measure: Change from baseline in other ocular morphologic measures at 12 months and 24 months
timeFrame: At the Week 48 and Week 96 visits
Other outcomes:
Locations:
city: Hefei
country: China
facility: Hefei Maternal and Child Health Hospital
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Anhui Medical University
state: Anhui
city: Xuancheng
country: China
facility: Xuancheng People's Hospital
state: Anhui
city: Lanzhou
country: China
facility: The Second Hospital of Lanzhou University
state: Gansu
city: Liuzhou
country: China
facility: Liuzhou People's Hospital
state: Guangxi Zhuang Autonomous Region
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi Zhuang Autonomous Region
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zunyi
country: China
facility: The First People's Hospital of Zunyi
state: Guizhou
city: Daqing
country: China
facility: Daqingshi People's Hospital
state: Heilongjiang
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Huai'an
country: China
facility: Huai'an First People's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Affiliated Eye Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Weifang
country: China
facility: Weifang Eye Hospital
state: Shandong
city: Changzhi
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Eye Hospital
state: Shanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shanxi
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tongren Hospital Affiliated to Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chongqing
country: China
facility: Chongqing Aier Eye Hospital
city: Shanghai
country: China
facility: Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital)
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
Study officials:
affiliation: Beijing Tongren Hospital Affiliated to Capital Medical University
name: Ningli Wang, Postdoctoral
role: PRINCIPAL_INVESTIGATOR
References: