The Effectiveness and Safety of Two Low-concentration Atropine Sulfate Eye Drops (0.01%/0.02%) for Delaying the Pediatric Myopia Progression

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Myopia, Myopia Progression

In brief

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.

Key facts

Study ID

NCT06708156

Run by

Oupushifang Pharmaceutical Technology Co., Ltd.

People needed

606

Starts

2024-06-15

Expected to finish

2027-12-31

Last updated by the study team

2024-12-24

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hefei Maternal and Child Health Hospital — Hefei, Anhui, China (enrolling)
• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Xuancheng People's Hospital — Xuancheng, Anhui, China (enrolling)
• The Second Hospital of Lanzhou University — Lanzhou, Gansu, China (enrolling)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (enrolling)
• The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China (enrolling)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (enrolling)
• The First People's Hospital of Zunyi — Zunyi, Guizhou, China (enrolling)
• Daqingshi People's Hospital — Daqing, Heilongjiang, China (enrolling)
• Kaifeng Central Hospital — Kaifeng, Henan, China (enrolling)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (enrolling)
• Huai'an First People's Hospital — Huai'an, Jiangsu, China (enrolling)
• Affiliated Eye Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• Weifang Eye Hospital — Weifang, Shandong, China (enrolling)
• Heping Hospital Affiliated to Changzhi Medical College — Changzhi, Shanxi, China (enrolling)
• Shanxi Eye Hospital — Taiyuan, Shanxi, China (enrolling)
• Xianyang Hospital of Yan'an University — Xianyang, Shanxi, China (enrolling)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (enrolling)
• Beijing Tongren Hospital Affiliated to Capital Medical University — Beijing, China (enrolling)
• Peking University Third Hospital — Beijing, China (enrolling)
• Chongqing Aier Eye Hospital — Chongqing, China (enrolling)
• Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital) — Shanghai, China (enrolling)
• Tianjin Medical University Eye Hospital — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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