Testing low-dose atropine eye drops to slow down myopia in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of two low-concentration atropine sulfate eye drops (0.01% and 0.02%) over a period of 96 weeks in delaying the progression of myopia in children and adolescents aged 6 to 12 years. Participants will be randomly assigned to receive either the atropine drops or a placebo, with the primary goal of assessing how well these treatments can slow myopia progression. Additionally, the study will explore the safety of these eye drops and investigate any rebound effects after discontinuation of treatment. The trial aims to provide valuable insights into managing pediatric myopia effectively.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hefei Maternal and Child Health Hospital
  Hefei, Anhui, China Recruiting
• The Second Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Xuancheng People's Hospital
  Xuancheng, Anhui, China Recruiting
• The Second Hospital of Lanzhou University
  Lanzhou, Gansu, China Recruiting
• Liuzhou People's Hospital
  Liuzhou, Guangxi, China Recruiting
• The People's Hospital of Guangxi Zhuang Autonomous Region
  Nanning, Guangxi, China Recruiting

Study contacts

• Principal investigator: Ningli Wang, Postdoctoral — Beijing Tongren Hospital Affiliated to Capital Medical University
• Study coordinator: Liang Gao
• Email: 9071044822@qq.com
• Phone: 0086-15056564539

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.