Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Children Myopia
About this trial
This is an interventional treatment trial for Children Myopia
Eligibility Criteria
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
Sites / Locations
- HanGil Eye Hospital
- Kangbuk Samsung Medical Center
- Konkuk University Medical Center
- Nowon Eulji Medical Center, Eulji University
- Samsung Medical Center
- Seoul Asan Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
SAT-001
Control Group
Wearing glasses or not