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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20240786 | Registry Identifier | National Medical Products Administration, NMPA |
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| Name | Class |
|---|---|
| Seefunge Pharmaceutical Technology Co., Ltd. | INDUSTRY |
| AUTEK China Inc. | UNKNOWN |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group (0.01% atropine sulfate eye drops) | Active Comparator | 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. |
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| Experimental group (0.02% atropine sulfate eye drops) | Active Comparator | 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. |
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| Control group (placebo eye drops) | Placebo Comparator | 1 drop in each eye, once a day, every night before sleep, gently press the dacryocyst on both sides for about 1 minute. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine sulfate eye drops 0.01% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effective change from baseline in equivalent spherical refraction at 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 | At the Week 96 visit |
| Measure | Description | Time Frame |
|---|---|---|
| Effective change from baseline in eye axis length at 24 months | Value of change from baseline in eye axis length at 24 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 96 visit |
| Effective change from baseline in refraction at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang Gao | Contact | 0086-15056564539 | 9071044822@qq.com | |
| Shaolong XUE, Dr. | Contact | 0086-18565027687 | xuesl@seefunge.com |
| Name | Affiliation | Role |
|---|---|---|
| Ningli Wang, Postdoctoral | Beijing Tongren Hospital Affiliated to Capital Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hefei Maternal and Child Health Hospital | Recruiting | Hefei | Anhui | China |
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Masking aims to achieve the unpredictability of randomized treatment groups by all parties involved in a clinical trial. To reduce the influence of evaluation bias or other factors, a double-blind experimental design was adopted in this study. Placebo is the auxiliary ingredient of atropine sulfate eye drops, and its specification, color, smell, etc. are consistent with the test drug and do not contain the active ingredient of the test drug. The drug in the experimental group was packaged in the same packaging as the placebo, and blinded according to random numbers to ensure that both the investigator and the subject were masked.
| Atropine sulfate eye drops 0.02% | Drug | 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 | 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. |
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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) |
| At the Week 48 visit |
| Effective change from baseline in ocular axis length at 12 months | Change from baseline in ocular axis length at 12 months of dosing (0.02% atropine vs. placebo; 0.01% atropine vs. placebo) | At the Week 48 visit |
| Progression of refraction ≤0.50 D at 12 months and 24 months and percentage | 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) | At the Week 48 and Week 96 visits |
| Progression of refraction ≤0.75D at 12 months and 24 months and percentage | 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) | At the Week 48 and Week 96 visits |
| Progression of refraction ≤1.00D at 12 months and 24 months and percentage | 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) | At the Week 48 and Week 96 visits |
| Progression of refraction >1.00D at 12 months and 24 months and percentage | 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) | At the Week 48 and Week 96 visits |
| Percentage of patients with 30% and 50% reduction in myopia progression at 12 and 24 months | 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) | At the Week 48 and Week 96 visits |
| Change from baseline in other ocular morphologic measures at 12 months and 24 months | 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) | At the Week 48 and Week 96 visits |
| The Second Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | China |
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| Xuancheng People's Hospital | Recruiting | Xuancheng | Anhui | China |
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| The Second Hospital of Lanzhou University | Recruiting | Lanzhou | Gansu | China |
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| Liuzhou People's Hospital | Recruiting | Liuzhou | Guangxi | China |
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| The People's Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | Guangxi | China |
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| The Affiliated Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | China |
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| The First People's Hospital of Zunyi | Recruiting | Zunyi | Guizhou | China |
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| Daqingshi People's Hospital | Recruiting | Daqing | Heilongjiang | China |
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| Kaifeng Central Hospital | Recruiting | Kaifeng | Henan | China |
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| The First Affiliated Hospital of University of South China | Recruiting | Hengyang | Hunan | China |
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| Huai'an First People's Hospital | Recruiting | Huai'an | Jiangsu | China |
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| Affiliated Eye Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| The Second Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| Weifang Eye Hospital | Recruiting | Weifang | Shandong | China |
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| Heping Hospital Affiliated to Changzhi Medical College | Recruiting | Changzhi | Shanxi | China |
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| Shanxi Eye Hospital | Recruiting | Taiyuan | Shanxi | China |
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| Xianyang Hospital of Yan'an University | Recruiting | Xianyang | Shanxi | China |
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| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Beijing Tongren Hospital Affiliated to Capital Medical University | Recruiting | Beijing | China |
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| Peking University Third Hospital | Recruiting | Beijing | China |
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| Chongqing Aier Eye Hospital | Recruiting | Chongqing | China |
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| Shanghai Eye Disease Prevention and Treatment Center (Shanghai Eye Hospital) | Recruiting | Shanghai | China |
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| Tianjin Medical University Eye Hospital | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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