Clinical trial NCT06344572: Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
Official title: A Multicenter, Randomized, Open-label, Controlled Pivotal Study to Evaluate the Efficacy and Safety of Software SAT-001 in Slowing Myopia Progression and Treatment in Pediatric Patients With Myopia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: S-Alpha Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-03
Enrollment: 110
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Children aged 5 to less than 9
2. Meet the following refractive criteria by cycloplegic refraction

   1. Spherical equivalent refractive error (SER): -0.75 to less than -6.00 D in each eye
   2. Astigmatism of 1.50 D or less in each eye
   3. Anisometropia of 2.00 D or less
3. Best corrected visual acuity of 0.2 logMAR or better in each eye at the Screening Visit
4. Able to successfully accomplish SAT-001, the investigational device (able to follow the written and verbal instruction)
5. Subjects and their legal guardians who agree to participate in the clinical trial and are willing to provide the signed informed consent after receiving and comprehending the explanation of the description of this clinical trial (subject under 6 can make a mark for agreement after full information and understanding)

Exclusion Criteria:

1. History of atropine use within 3 days prior to Baseline (Visit 2) (prior treatment of 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., or presence 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, intraocular surgery, 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 other clinical trial medications or investigational device
8. Clinically significant systemic diseases such as congenital heart disease, respiratory disease, endocrine disease, and neurological disease that the investigator 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

Primary outcomes:
measure: Change in Cycloplegic Spherical Equivalent Refractive Error
timeFrame: Baseline, 48weeks
Secondary outcomes:
measure: Change in Cycloplegic Spherical Equivalent Refractive Error
timeFrame: Baseline, 24weeks
measure: Change in Axial Length
timeFrame: Baseline, 12weeks, 24weeks, 36weeks, 48weeks
measure: Change in cycloplegic Spherical Equivalent Refractive Error relative to baseline depending on the myopia severity(mild myopia, moderate myopia)
timeFrame: Baseline, 24 weeks, 48 weeks
measure: Change in axial length relative to baseline depending on the myopia severity(mild myopia, moderate myopia)
timeFrame: Baseline, 12weeks, 24weeks, 36weeks, 48weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
Study officials:
References: