MyopiaNCT06742268
Extension Study on Safety and Rebound Effect of SAT-001 for Myopia in Children
An observational study of Myopia, run by S-Alpha Therapeutics, Inc. at 5 sites in South Korea.
Trial summary
The objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients. Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Myopia
- What is being tested?
- Single vision spectacles
- How many people
- 40 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 16 Dec 2024to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of children aged 5 to 8 years at the time of their participation in the previous confirmatory trial (SAT-001-KP-002), who are continuing in the extension study. Participants will remain in their original groups (study or control group) with no new randomization.
Who may be able to join
- Participants who have completed the previous clinical trial (SAT001-KP-002), and their legal guardians who agree to participate in this extension study 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)
Who cannot join
- Participants in the study group of the previous clinical trial (SAT001-KP-002) with a compliance rate of less than 70% (overall compliance throughout the study period).
- Other reasons for participation in the trial at the discretion of the investigator
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
South Korea5 sites, 5 recruiting
- Not yet recruiting
Chung-Ang University Gwang Myeong Hospital
Gwangmyeong, 14323
Kim, MD
Kim, MD
- Recruiting
Hallym University Dongtan Sacred heart Hospital
Hwaseong-si, Gyeonggi-do
Rhiu, MD
Rhiu, MD
- Recruiting
Gachon University Gil Medical Center
Incheon, 42724
Baik, MD
Baik, MD
- Recruiting
Kangbuk Samsung Hospital
Seoul, Choose One..., 01757
Han, MD
Han, MD
- Not yet recruiting
Seoul Asan Medical Center
Seoul, Choose One..., 05505
Lee, MD
Lee
About this study
Official title: A Multi-center, Open-label, Controlled Extension Study to Evaluate the Rebound Effect and Long-term Safety of Software SAT-001 for the Inhibition of Myopia Progression and Treatment in Pediatric Patients With Myopia
The objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients.
Read the detailed description
Myopia treatments to date have included both pharmacological and non-pharmacological approaches, with some studies showing effects in reducing myopia progression. However, previous research has also identified a rebound effect, where myopia progresses rapidly after treatment cessation during follow-up. Since myopia progression in children often continues for more than two years, this rebound effect could be a critical factor in determining treatment strategies for pediatric myopia.
This multi-center, open-label, controlled observational study is an extension of a previous confirmatory trial (SAT-001-KP-002) that evaluated SAT-001, a Software as a Medical Device (SaMD) designed to slow myopia progression in pediatric patients. The current study aims to assess the rebound effect and long-term safety of SAT-001 in participants who completed the previous trial, and to collect additional data on rebound myopia and long-term safety outcomes following the completion of the initial trial. A total of 40 participants, aged 5 to less than 9 years, from both the treatment and control groups of the prior study will be followed for 6 months after completing the original trial. Participants from the previous trial who had less than 70% compliance will be excluded from this study. Both groups will continue wearing spectacles, the conventional treatment for myopia, during the extension phase. The primary endpoint is the change in cycloplegic spherical equivalent refractive error (SER) from baseline to 24 weeks, while secondary endpoints include changes in SER at 12 weeks and changes in axial length at 12 and 24 weeks compared to baseline.
- Conditions
- Myopia
- Being tested
- Single vision spectacles
- Keywords
- Myopia, Rebound effect, SaMD
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single vision spectaclesOther
Other interventions for myopia treatment, except for glasses, will not be provided.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Spectacles with Cessation of SAT-001 Use | This group consists of pediatric participants who were previously assigned to receive SAT-001 along with single vision spectacles as part of the SAT-001 confirmatory trial (SAT-001-KP-002). In the extension phase, these participants will continue wearing single vision spectacles, but will no longer receive SAT-001 treatment. The aim is to monitor rebound myopia and long-term safety after the completion of the initial trial, focusing on any changes in refractive error and axial length, as well as any adverse effects associated with the cessation of SAT-001 use. Receives: Other: Single vision spectacles | |
| Arm 2: Continued Spectacles Only | This group consists of pediatric participants who were assigned to the control group during the SAT-001 confirmatory trial and received only single vision spectacles. In the extension phase, they will continue wearing spectacles to assess rebound myopia and long-term safety, without the addition of SAT-001 treatment. Receives: Other: Single vision spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in spherical equivalent refractive error
change in spherical equivalent refractive error at 24 weeks from baseline
Measured: baseline, 24 weeks
Secondary outcomes (2)
change in spherical equivalent refractive error
change in spherical equivalent refractive error at 12- and 24-week from baseline
Measured: Baseline, 12 weeks, 24 weeks
change in axial length
change in axial length at 12-week and 24-week from baseline
Measured: Baseline, 12 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start16 Dec 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S-Alpha Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paik, MD, Principal investigator, Gachon University Gil Medical CenterLee, MD, Principal investigator, Seoul Asan Medical CenterHan, MD, Principal investigator, Kangbuk Samsung HospitalKim, MD, Principal investigator, HanGil Eye HospitalKim, MD, Principal investigator, Chung-Ang University Gwang Myeong HospitalPark, MD, Principal investigator, Daegu Fatima HospitalRhiu, MD, Principal investigator, Hallym University Dongtan Sacred Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06742268
- Sponsor's protocol ID
- SAT001-KP-003
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Controlled Extension Study to Evaluate the Rebound Effect and Long-term Safety of Software SAT-001 for the Inhibition of Myopia Progression and Treatment in Pediatric Patients With Myopia
- ClinicalTrials.gov ID
- NCT06742268
- Acronym / sponsor ID
- SAT001-KP-003
- Conditions
- Myopia
- Keywords
- Myopia, Rebound effect, SaMD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- S-Alpha Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 19 Dec 2024 (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 objective of this clinical trial is to collect data on the rebound effect and long-term safety of SAT-001, a Software as a Medical Device (SaMD) under development for the inhibition and treatment of myopia progression in pediatric patients.
Detailed description
Myopia treatments to date have included both pharmacological and non-pharmacological approaches, with some studies showing effects in reducing myopia progression. However, previous research has also identified a rebound effect, where myopia progresses rapidly after treatment cessation during follow-up. Since myopia progression in children often continues for more than two years, this rebound effect could be a critical factor in determining treatment strategies for pediatric myopia.
This multi-center, open-label, controlled observational study is an extension of a previous confirmatory trial (SAT-001-KP-002) that evaluated SAT-001, a Software as a Medical Device (SaMD) designed to slow myopia progression in pediatric patients. The current study aims to assess the rebound effect and long-term safety of SAT-001 in participants who completed the previous trial, and to collect additional data on rebound myopia and long-term safety outcomes following the completion of the initial trial. A total of 40 participants, aged 5 to less than 9 years, from both the treatment and control groups of the prior study will be followed for 6 months after completing the original trial. Participants from the previous trial who had less than 70% compliance will be excluded from this study. Both groups will continue wearing spectacles, the conventional treatment for myopia, during the extension phase. The primary endpoint is the change in cycloplegic spherical equivalent refractive error (SER) from baseline to 24 weeks, while secondary endpoints include changes in SER at 12 weeks and changes in axial length at 12 and 24 weeks compared to baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Spectacles with Cessation of SAT-001 Use | – | Other: Single vision spectaclesThis group consists of pediatric participants who were previously assigned to receive SAT-001 along with single vision spectacles as part of the SAT-001 confirmatory trial (SAT-001-KP-002). In the extension phase, these participants will continue wearing single vision spectacles, but will no longer receive SAT-001 treatment. The aim is to monitor rebound myopia and long-term safety after the completion of the initial trial, focusing on any changes in refractive error and axial length, as well as any adverse effects associated with the cessation of SAT-001 use. |
| Arm 2: Continued Spectacles Only | – | Other: Single vision spectaclesThis group consists of pediatric participants who were assigned to the control group during the SAT-001 confirmatory trial and received only single vision spectacles. In the extension phase, they will continue wearing spectacles to assess rebound myopia and long-term safety, without the addition of SAT-001 treatment. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of children aged 5 to 8 years at the time of their participation in the previous confirmatory trial (SAT-001-KP-002), who are continuing in the extension study. Participants will remain in their original groups (study or control group) with no new randomization.
Key inclusion criteria (1 listed)
- Participants who have completed the previous clinical trial (SAT001-KP-002), and their legal guardians who agree to participate in this extension study 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)
Key exclusion criteria (2 listed)
- Participants in the study group of the previous clinical trial (SAT001-KP-002) with a compliance rate of less than 70% (overall compliance throughout the study period).
- Other reasons for participation in the trial at the discretion of the investigator
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 |
|---|---|---|
| Single vision spectaclesOther interventions for myopia treatment, except for glasses, will not be provided. | Other | Arm 1: Spectacles with Cessation of SAT-001 Use, Arm 2: Continued Spectacles Only |
Primary outcome
change in spherical equivalent refractive error
Time frame: baseline, 24 weeks
change in spherical equivalent refractive error at 24 weeks from baseline
2 secondary outcomes
change in spherical equivalent refractive error
Time frame: Baseline, 12 weeks, 24 weeks
change in axial length
Time frame: Baseline, 12 weeks, 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Paik, MD principal investigator
Gachon University Gil Medical Center
Lee, MD principal investigator
Seoul Asan Medical Center
Han, MD principal investigator
Kangbuk Samsung Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by S-Alpha Therapeutics, Inc. at 5 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jihye Lee, MSc ((+82) 2-3487-3923, sophie@salphadtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in spherical equivalent refractive error (time frame: baseline, 24 weeks). 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 9 Jan 2025.