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

NCT ID: NCT05917041

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-05
• Study Completion Date: 2024-04-03

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

Conditions

Children Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SAT-001

Group Type: EXPERIMENTAL

SAT-001(Software as Medical Device)

Intervention Type: DEVICE

Using SAT-001 application for 48 weeks and wearing glasses or not

Control Group

Wearing glasses or not

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

SAT-001(Software as Medical Device)

Using SAT-001 application for 48 weeks and wearing glasses or not

Intervention Type: DEVICE

Eligibility Criteria

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)

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

2. Astigmatism of 1.50 D or less in each eye

3. Anisometropia of less than 1.00 D

3. The age of birth over 38 weeks

4. Over 2500g of birth weight

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

6. 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

S-Alpha Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

HanGil Eye Hospital

Incheon, , South Korea

Kangbuk Samsung Medical Center

Seoul, , South Korea

Konkuk University Medical Center

Seoul, , South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Samsung Medical Center

Seoul, , South Korea

Seoul Asan Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

SAT001-KP-001

Identifier Type: -

Identifier Source: org_study_id