Clinical trial NCT05917041: Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children Myopia
Lead sponsor: S-Alpha Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-23
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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

Eligibility criteria: Inclusion Criteria:

1. Pediatric patient age 5 to 12 years old at the Screening Visit
2. Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)

   1. Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye
   2. Astigmatism of 1.50 D or less in each eye
   3. Anisometropia of less than 1.00 D
3. The age of birth over 38 weeks
4. Over 2500g of birth weight
5. Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
6. Intraocular pressure 21 mmHg or less in each eye at the Screening Visit

Exclusion Criteria:

1. Administration of anti-muscarine drugs within 1 month before screening visit
2. Current or previous use of multi-focal lenses
3. 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
4. History of atropine use for treatment of myopia within 1 month before screening visit
5. Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit
6. History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision)
7. History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery)
8. Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD)
9. Down's syndrome or cerebral palsy
10. Participation in another clinical trial within 6 months before screening visit
11. History of growth hormone treatment within 1 month before screening visit
12. Medically clear to have abnormal range of intellectual development
13. Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease
14. 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
15. History of injections with histamine release and cholinergic effect within 30 days before screening visit
16. Incongruent to participate in this study at the discretion of the investigator

Primary outcomes:
measure: Change in cycloplegic Refraction Error
timeFrame: Baseline, 24 weeks, 48 weeks
measure: Change in axial length
timeFrame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: HanGil Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan Medical Center
Study officials:
References: