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

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 consentvoluntarily.

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 (automaticoptometry 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 inclusionscreening.

5. The antimetropia (measured by equivalent spherical refraction) is < 2.00 D atinclusion screening.

6. Able to comply with study requirements, attend all study visits (including telephonevisits), 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 ascataracts, glaucoma, fundus macular disease, keratopathy, uveitis, retinaldetachment, severe vitreous opacity, etc., manifest strabismus, nystagmus, ocularacute inflammatory disease), history of recurrent chronic ocular inflammation, orany 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 (includingvarious 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 agentsfor examinations such as optometry is allowed), and others (including traditionalChinese medicine, auricular acupuncture, massage, accommodative flippers, red lighttherapy instrument, etc.) within 3 months before screening.

6. Those who have participated in other clinical trials and received drug or medicaldevice interventions within 3 months before screening.

7. Systemic or topical use of drugs that affect the efficacy evaluation, such asanticholinergics: atropine, pirenzepine, etc., and cholinomimetics: pilocarpine,etc. within 1 week before screening.

8. Combined with severe immune system disease, central nervous system disease, Downsyndrome, asthma, cardiopulmonary insufficiency, liver and kidney dysfunction, etc.

9. Surgical intervention (ocular or systemic) within 6 months before screening, orplanned 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 perminute, the ECG should be retested 10 minutes later. If the retest result below 120beats/min, the screening is successful; If the retest result is still >120beats/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 oralsteroids (i.e., continuous use for < 2 weeks).

12. Other conditions that are considered unsuitable by the investigator.