Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia

Study Overview
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Brief Summary
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The Purpose of this study is to explore the safety and effectiveness of SAT-001, a medical device for the treatment of myopia in pediatric patient with myopia

Detailed Description
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Myopic pediatric prevalence rate come to increase rapidly globally. This is a clinical trial to explore the safety and effectiveness of SAT-001(as a Software as Medical Device) developed for the treatment of myopia through suppressing the progress myopia

Official Title
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A Randomised, Open-label, Multicenter, Controlled, Exploratory Study on the Effect and Safety of SAT-001 as a Medical Device in Treatment of Pediatric Patients With Myopia

Conditions
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Children Myopia

Intervention / Treatment
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* Device: SAT-001(Software as Medical Device)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patient age 5 to 12 years old at the Screening Visit Diagnosed with myopia as following refractive error via cycloplegic refraction(CR) Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye Astigmatism of 1.50 D or less in each eye Anisometropia of less than 1.00 D The age of birth over 38 weeks Over 2500g of birth weight Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit Intraocular pressure 21 mmHg or less in each eye at the Screening Visit Exclusion Criteria: Administration of anti-muscarine drugs within 1 month before screening visit Current or previous use of multi-focal lenses Planning to use or having used Orthokeratology lenses (Ortho-K lenses), Rigid Gas Permeable (RGP) lenses, and other contact lenses to reduce the progression of myopia History of atropine use for treatment of myopia within 1 month before screening visit Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision) History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery) Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD) Down's syndrome or cerebral palsy Participation in another clinical trial within 6 months before screening visit History of growth hormone treatment within 1 month before screening visit Medically clear to have abnormal range of intellectual development Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease Currently taking or having taken antihistamines (tablets, nasal spray, eye drops, etc.) or psychiatric drugs (antidepressants, anti-anxiety medications, etc.) within 30 days before screening visit History of injections with histamine release and cholinergic effect within 30 days before screening visit Incongruent to participate in this study at the discretion of the investigator

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAT-001<br> | Device: SAT-001(Software as Medical Device)<br>* Using SAT-001 application for 48 weeks and wearing glasses or not<br>|
| No Intervention: Control Group<br>Wearing glasses or not | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cycloplegic Refraction Error |  | Baseline, 24 weeks, 48 weeks | 
| Change in axial length |  | Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks |