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

Phase 3

Recruiting

• Conditions: Myopia; Myopia Progression
• Interventions: Drug: Placebo eye drops; Drug: Atropine sulfate eye drops 0.01%; Drug: Atropine sulfate eye drops 0.02%

• Registration Number: NCT06708156
• Lead Sponsor: Oupushifang Pharmaceutical Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-15
• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-24
• Study First Posted: 2024-11-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 606

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group (placebo eye drops)	Placebo eye drops	1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Experimental group (0.01% atropine sulfate eye drops)	Atropine sulfate eye drops 0.01%	1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.
Experimental group (0.02% atropine sulfate eye drops)	Atropine sulfate eye drops 0.02%	1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute.

Primary Outcome Measures

Name	Time	Method
Effective change from baseline in equivalent spherical refraction at Week 96 visit	At the Week 96 visit	The inter-group difference in the value of change from baseline in equivalent spherical refraction after 0.01% or 0.02% atropine sulfate eye drops versus placebo under a cycloplegia condition at the Week 96 visit

Secondary Outcome Measures

Name	Time	Method
Effective change from baseline in eye axis length at 24 months	At the Week 96 visit	Value of change from baseline in eye axis length at 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Effective change from baseline in refraction at 12 months	At the Week 48 visit	Change from baseline in refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) at 12 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Effective change from baseline in ocular axis length at 12 months	At the Week 48 visit	Change from baseline in ocular axis length at 12 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Progression of refraction ≤0.50 D at 12 months and 24 months and percentage	At the Week 48 and Week 96 visits	Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.50 D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Progression of refraction ≤0.75D at 12 months and 24 months and percentage	At the Week 48 and Week 96 visits	Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤0.75D at 12 months and 24 months and percentage (0.02% atropine vs placebo; 0.01% atropine vs placebo)
Progression of refraction ≤1.00D at 12 months and 24 months and percentage	At the Week 48 and Week 96 visits	Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) ≤1.00D at 12 months and 24 months (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Progression of refraction >1.00D at 12 months and 24 months and percentage	At the Week 48 and Week 96 visits	Progression of refraction (automatic optometric equivalent spherical refraction under a cycloplegia condition) \>1.00D at 12 months and 24 months of dosing and percentage (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)
Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months	At the Week 48 and Week 96 visits	Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months of medication compared to control (0.02% atropine versus placebo; 0.01% atropine versus placebo)
Change from baseline in other ocular morphologic measures at 12 months and 24 months	At the Week 48 and Week 96 visits	Change from baseline in other ocular morphologic measures (e.g., corneal curvature, vitreous chamber depth, choroidal thickness) at 12 months and 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo)

Trial Locations

Locations (25)

Hefei Maternal and Child Health Hospital; 🇨🇳 Hefei, Anhui, China

The Second Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Xuancheng People's Hospital; 🇨🇳 Xuancheng, Anhui, China

The Second Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Liuzhou People's Hospital; 🇨🇳 Liuzhou, Guangxi Zhuang Autonomous Region, China

The People's Hospital of Guangxi Zhuang Autonomous Region; 🇨🇳 Nanning, Guangxi Zhuang Autonomous Region, China

The Affiliated Hospital of Guizhou Medical University; 🇨🇳 Guiyang, Guizhou, China

The First People's Hospital of Zunyi; 🇨🇳 Zunyi, Guizhou, China

Daqingshi People's Hospital; 🇨🇳 Daqing, Heilongjiang, China

Kaifeng Central Hospital; 🇨🇳 Kaifeng, Henan, China

The First Affiliated Hospital of University of South China; 🇨🇳 Hengyang, Hunan, China

Huai'an First People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

Affiliated Eye Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Weifang Eye Hospital; 🇨🇳 Weifang, Shandong, China

Heping Hospital Affiliated to Changzhi Medical College; 🇨🇳 Changzhi, Shanxi, China

Shanxi Eye Hospital; 🇨🇳 Taiyuan, Shanxi, China

Xianyang Hospital of Yan'an University; 🇨🇳 Xianyang, Shanxi, China

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Tongren Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Chongqing Aier Eye Hospital; 🇨🇳 Chongqing, China

Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital); 🇨🇳 Shanghai, China

Tianjin Medical University Eye Hospital; 🇨🇳 Tianjin, China