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

• Sponsor: S-Alpha Therapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05917041
• Collaborator: (none)
• Enrollment: 60
• Locations: 6
• Arms: 2
• Anticipated Duration (Months): 37.5
• Patients Per Site: 10
• Patients Per Site Per Month: 0.3

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Children Myopia	Device: SAT-001(Software as Medical Device)	N/A

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

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 5, 2021
• Actual Primary Completion Date: Apr 19, 2023
• Anticipated Study Completion Date: Apr 18, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SAT-001	Device: SAT-001(Software as Medical Device); Using SAT-001 application for 48 weeks and wearing glasses or not
No Intervention: Control Group Wearing glasses or not

Outcome Measures

Primary Outcome Measures

1. Change in cycloplegic Refraction Error [Baseline, 24 weeks, 48 weeks]

2. Change in axial length [Baseline, 12 weeks, 24 weeks, 36 weeks, 48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 12 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Pediatric patient age 5 to 12 years old at the Screening Visit

2. Diagnosed with myopia as following refractive error via cycloplegic refraction(CR)

3. Spherical equivalent (SE) -0.75 D or more and less than -6.00 D in each eye

4. Astigmatism of 1.50 D or less in each eye

5. Anisometropia of less than 1.00 D

6. The age of birth over 38 weeks

7. Over 2500g of birth weight

8. Best corrected distance visual acuity of 0.2 logMAR or better in each eye at the Screening Visit

9. Intraocular pressure 21 mmHg or less in each eye at the Screening Visit

Exclusion Criteria:

1. Administration of anti-muscarine drugs within 1 month before screening visit

2. Current or previous use of multi-focal lenses

3. 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

4. History of atropine use for treatment of myopia within 1 month before screening visit

5. Abnormal conditions in cornea, lens, central retina, iris and ciliary bodies or malignant tumors around orbit

6. History of manifest strabismus, intermittent strabismus, amblyopia, nystagmus etc. (except for phoria maintaining binocular vision)

7. History of ophthalmic surgery, such as eyelid surgery, strabismus surgery, intraocular surgery, or refractive correction surgery (except for epiblepharon surgery)

8. Obsessive-compulsive disorder or attention deficit hyperactivity disorder(ADHD)

9. Down's syndrome or cerebral palsy

10. Participation in another clinical trial within 6 months before screening visit

11. History of growth hormone treatment within 1 month before screening visit

12. Medically clear to have abnormal range of intellectual development

13. Significant systemic diseases such as congenital heart disease, respiratory system disease (except for asthma), endocrine disease or nervous system disease

14. 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

15. History of injections with histamine release and cholinergic effect within 30 days before screening visit

16. Incongruent to participate in this study at the discretion of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	HanGil Eye Hospital	Incheon		Korea, Republic of
2	Kangbuk Samsung Medical Center	Seoul		Korea, Republic of
3	Konkuk University Medical Center	Seoul		Korea, Republic of
4	Nowon Eulji Medical Center, Eulji University	Seoul		Korea, Republic of
5	Samsung Medical Center	Seoul		Korea, Republic of
6	Seoul Asan Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

• S-Alpha Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S-Alpha Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05917041
• Other Study ID Numbers: SAT001-KP-001
• First Posted: Jun 23, 2023
• Last Update Posted: Jun 23, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Jun 23, 2023