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Clinical Trials in China / NCT06708156
Recruiting Phase 3

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

NCT06708156 · tracked via the Priya Life Science China tracker
Sponsor
Oupushifang Pharmaceutical Technology Co., Ltd.
Phase
Phase 3
Started
2024-06-15
Last updated
2024-12-24

Condition(s) studied

MyopiaMyopia Progression

Investigational drug(s) / intervention(s)

Atropine sulfate eye drops 0.01%Atropine sulfate eye drops 0.02%Placebo eye drops

Atropine sulfate eye drops 0.01%: Drug: 0.01% atropine sulfate eye drops Dosage form and strength: 0.01% (0.4 mL: 0.04 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Atropine sulfate eye drops 0.02%: Drug: 0.02% atropine sulfate eye drops Dosage form and strength: 0.02% (0.4 mL: 0.08 mg) eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Placebo eye drops: Drug: placebo eye drops Dosage form and strength: 0.4 mL eye drops Usage: both eyes, 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Study 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

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (25)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06708156 on ClinicalTrials.gov ↗ ← All trials in China