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

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

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

Study Overview

• Status: Completed
• Conditions: Children Myopia
• Intervention / Treatment: Device: SAT-001(Software as Medical Device)

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Hangil Eye Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Kangbuk Samsung Medical Center
  • Seoul, Korea, Republic of
    • Seoul Asan Medical Center
  • Seoul, Korea, Republic of
    • Nowon Eulji Medical Center, Eulji University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: S-Alpha Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2021
• Primary Completion (Actual): April 19, 2023
• Study Completion (Actual): April 3, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SAT001-KP-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No