Children MyopiaNCT05917041
Exploratory Study of SAT-001 in Treatment of Pediatric Patient With Myopia
A study testing SAT-001(Software as Medical Device) in people with Children Myopia, run by S-Alpha Therapeutics, Inc. at 6 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Children Myopia
- What is being tested?
- SAT-001(Software as Medical Device)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 5 Mar 2021to 3 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
HanGil Eye Hospital
Incheon
Kangbuk Samsung Medical Center
Seoul
Konkuk University Medical Center
Seoul
Nowon Eulji Medical Center, Eulji University
Seoul
Samsung Medical Center
Seoul
Seoul Asan Medical Center
Seoul
About this study
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
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
Read the 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
- Conditions
- Children Myopia
- Being tested
- SAT-001(Software as Medical Device)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAT-001(Software as Medical Device)Device
Using SAT-001 application for 48 weeks and wearing glasses or not
| Study group | Role | What they receive |
|---|---|---|
| SAT-001 | Experimental | Not described Receives: Device: SAT-001(Software as Medical Device) |
| Control Group | No intervention | Wearing glasses or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cycloplegic Refraction Error
Measured: Baseline, 24 weeks, 48 weeks
Change in axial length
Measured: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start5 Mar 2021
- Primary completion19 Apr 2023
- Study completion3 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- S-Alpha Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917041
- Sponsor's protocol ID
- SAT001-KP-001
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 3 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05917041
- Acronym / sponsor ID
- SAT001-KP-001
- Conditions
- Children Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- S-Alpha Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 3 Apr 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAT-001 | Experimental | Device: SAT-001(Software as Medical Device) |
| Control Group | No intervention | –Wearing glasses or not |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Pediatric patient age 5 to 12 years old at the Screening Visit
- Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAT-001(Software as Medical Device)Using SAT-001 application for 48 weeks and wearing glasses or not | Device | SAT-001 |
Primary outcome
Change in cycloplegic Refraction Error
Time frame: Baseline, 24 weeks, 48 weeks
Change in axial length
Time frame: Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAT-001(Software as Medical Device) in people with Children Myopia, run by S-Alpha Therapeutics, Inc. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cycloplegic Refraction Error (time frame: Baseline, 24 weeks, 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.