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

Last updated: January 8, 2025
Sponsor: S-Alpha Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

SAT-001

Single vision spectacles

Clinical Study ID

NCT06344572
SAT001-KP-002
  • Ages 5-8
  • All Genders

Study Summary

The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Children aged 5 to less than 9

  2. Meet the following refractive criteria by cycloplegic refraction

  3. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in eacheye

  4. Astigmatism of 1.50 D or less in each eye

  5. Anisometropia of 2.00 D or less

  6. Best corrected visual acuity of 0.2 logMAR or better in each eye at the ScreeningVisit

  7. Able to successfully accomplish SAT-001, the investigational device (able to followthe written and verbal instruction)

  8. Subjects and their legal guardians who agree to participate in the clinical trialand are willing to provide the signed informed consent after receiving andcomprehending the explanation of the description of this clinical trial (subjectunder 6 can make a mark for agreement after full information and understanding)

Exclusion

Exclusion Criteria:

  1. History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatmentof myopia control with low dose atropine within 1 month prior to Baseline)

  2. Current or prior use of multifocal lenses (e.g. progressive addition lenses),orthokeratology (Ortho-K, e.g. Dream lens), or Rigid gas permeable (RGP) within 1month prior to Baseline(Visit 2)

  3. Ocular abnormalities in cornea, lens, central retina, iris, ciliary body, etc., orpresence of malignant tumors in the orbital area

  4. History of eye diseases such as manifest strabismus, intermittent strabismus,amblyopia, and nystagmus (excluding strabismus that maintains binocular vision)

  5. History of ocular surgery such as eyelid surgery, strabismus surgery, intraocularsurgery, or refractive correction surgery (excluding simple double eyelid surgery)

  6. Down's syndrome or cerebral palsy

  7. Within 6 months prior to the Screening visit (Visit 1), has experience of otherclinical trial medications or investigational device

  8. Clinically significant systemic diseases such as congenital heart disease,respiratory disease, endocrine disease, and neurological disease that theinvestigator may consider inappropriate for participation in the clinical trials

  9. Systemic diseases that could impact both vision and visual field

  10. History of growth hormone treatment within 1 month prior to Baseline (Visit 2)

  11. Other reasons for participation in the trial at the discretion of the investigator

Study Design

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: SAT-001
Phase:
Study Start date:
September 27, 2023
Estimated Completion Date:
September 30, 2025

Study Description

Myopia is a common refractive error affecting approximately 30 % of the global population, with even higher prevalence in Asian countries including Korea. This study is a confirmatory clinical trial designed to evaluate the efficacy and safety of SAT-001 for slowing the progression of myopia in children, based on the results of the exploratory clinical trial.

Connect with a study center

  • Gachon University Gil Hospital

    Incheon,
    Korea, Republic of

    Active - Recruiting

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