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| Name | Class |
|---|---|
| Beijing Children's Hospital | OTHER |
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This study is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of atropine sulfate eye drops (0.01%) in treating transient myopia induced by near work tasks (NITM) in pediatric subjects.
All eligible subjects will be randomly assigned in a 1:1 ratio to either the 0.01% atropine sulfate eye drops group or the atropine sulfate eye drops vehicle placebo control group. Subjects in the treatment group will apply one drop of 0.01% atropine sulfate eye drops to each eye before going to bed at night, while subjects in the control group will apply one drop of the atropine sulfate eye drops vehicle placebo to each eye before going to bed at night. All eligible subjects will be randomly grouped and receive treatment for a period of 12 weeks. All subjects will be followed up according to the same timing and examination schedule. The follow-up time points will be on the 1st day, 14th day, and 12th week after administration, as well as 12 weeks after discontinuation of the medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% Atropine | Experimental | Atropine Sulfate Eye Drops, conc. 0.01% |
|
| Blank Solvent | Placebo Comparator | Blank solvent placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atropine Sulfate | Drug | low concentration atropine (0.01%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in initial NITM (Nearwork-induced transient myopia) values from baseline to week 12. | Compare the autorefractor NITM results measured in week 12 of the experimental and control group. | DAY 1 & Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in initial NITM values at week 2 and week 24 | Measure the initial NITM (Near-Induced Transient Myopia) values at the designed time point. | Week 2 and week 24 |
| Initial NITM values |
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Inclusion Criteria:
Exclusion Criteria:
Known contraindications or allergies to atropine sulfate, the study drug, or its components.
Clinically significant abnormal findings on slit-lamp microscopy examination (e.g., cataract) that may affect the measurement of best-corrected visual acuity in either eye at the time of screening, or known clinically significant findings from a previous slit-lamp microscopy examination in either eye.
Clinically significant abnormal findings on direct ophthalmoscopy at the time of screening in either eye, or known previous clinically significant retinal findings in either eye.
Evidence of any ocular motility disorder or restriction of extraocular muscle movement (e.g., nystagmus).
Presence of infectious eye diseases (such as bacterial, viral, or fungal infections).
Active ocular inflammation in either eye or a history of chronic or recurrent ocular inflammation (e.g., moderate to severe blepharitis, allergic conjunctivitis, peripheral ulcerative keratitis).
History of ocular herpes virus infection, iritis, scleritis, or uveitis, regardless of whether it is active at the time of screening.
Abnormal pupillary light reflex and/or amblyopia at the time of screening.
Intraocular pressure (IOP) in either eye <9mmHg or >21mmHg at the time of screening, or a difference in IOP between both eyes ≥5mmHg, or a previous diagnosis of ocular hypertension or glaucoma, or currently receiving any type of topical IOP-lowering (glaucoma) medication.
Received surgical intervention (ocular or systemic) within 6 months prior to the screening period, or planning to receive surgical intervention during the study period.
Use of any prohibited medication or treatment (ocular or periocular topical medication, systemic medication, injectable medication, and use of any lenses that can slow the progression of myopia) during the specified period before Visit 1. These medications or treatments are also prohibited during the study period. The shortest reasonable washout period for prohibited medications or treatments is:
Expected use of ocular or systemic oral corticosteroids during the study period.
Participation in any other experimental treatment study within 30 days before the screening period or during the study period.
History or current disease that makes the subject prone to secondary myopia (e.g., Marfan syndrome, Stickler syndrome) or may affect visual function or development (e.g., diabetes, chromosomal abnormalities).
Presence of any condition or situation that the investigator believes may increase the risk to the subject, confound study data, or severely interfere with the subject's participation in the study, including but not limited to unstable: cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immune, skin, hematological, neurological, or psychiatric diseases.
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoling Wang | Beijing Children's Hospital | Principal Investigator |
| Li Li | Beijing Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Children's Hospital, Capital Medical University | Beijing | China |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D001285 | Atropine |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Placebo | Drug | Blank comparator |
|
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Test the initial NITM (Near-Induced Transient Myopia) at each time point.
| Week 2 |
| Initial NITM values | Test the initial NITM (Near-Induced Transient Myopia) at each time point. | Week 12 |
| Initial NITM values | Test the initial NITM (Near-Induced Transient Myopia) at each time point. | Week 24 |
| The difference between the change in initial NITM values | The difference between the change in initial NITM values from baseline to week 12 and the change from baseline to week 24 | Day 1 & Week 12 & Week 24 |
| D009930 |
| Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |