search
Back to results

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

Primary Purpose

Children Myopia

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SAT-001(Software as Medical Device)
Sponsored by
S-Alpha Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children Myopia

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

No Intervention

Arm Label

SAT-001

Control Group

Arm Description

Wearing glasses or not

Outcomes

Primary Outcome Measures

Change in cycloplegic Refraction Error
Change in axial length

Secondary Outcome Measures

Full Information

First Posted
June 12, 2023
Last Updated
June 20, 2023
Sponsor
S-Alpha Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05917041
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 5, 2021 (Actual)
Primary Completion Date
April 19, 2023 (Actual)
Study Completion Date
April 18, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
S-Alpha Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAT-001
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Wearing glasses or not
Intervention Type
Device
Intervention Name(s)
SAT-001(Software as Medical Device)
Intervention Description
Using SAT-001 application for 48 weeks and wearing glasses or not
Primary Outcome Measure Information:
Title
Change in cycloplegic Refraction Error
Time Frame
Baseline, 24 weeks, 48 weeks
Title
Change in axial length
Time Frame
Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
HanGil Eye Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Nowon Eulji Medical Center, Eulji University
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs