A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

A Phase II Study to Determine the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution on Myopia Control in Subjects Aged 3-12 Years.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06579287

Enrollment

140

Registered

2024-08-30

Start date

2025-01-22

Completion date

2026-12-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Progressive

Keywords

Myopia

Brief summary

The objective of this study is to explore the safety and efficacy of SHJ002 Sterile Ophthalmic Solution relative to atropine in myopia control SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.

Interventions

DRUGSHJ002

Topical ophthalmic

DRUGAtropine

Topical ophthalmic

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

Inclusion criteria

1. Be male or female, age 3-12 years (inclusive). 2. Cycloplegic sphere of -1.00 D or worse in both eyes 3. Able to complete all study assessments and comply with the protocol 4. Literate or able to orally communicate. 5. Parent or guardian able and willing to provide written informed consent 6. Parent or guardian able and willing to assure subject compliance with the protocol, follow study instructions, and attend study visits 7. Able to tolerate eye drops in both eyes. 8. Be able and willing to avoid all disallowed medications and refractive correction 9. For female subjects of childbearing potential (those who have experienced menarche and who are not surgically sterilized \[bilateral tubal ligation, hysterectomy, or bilateral oophorectomy\]), a negative urinary test. 10. Women of childbearing potential must agree to use two reliable methods of contraception 11. Males not naturally or surgically sterile, who have a female partner of childbearing potential, must agree to use two reliable methods of contraception

Exclusion criteria

1. Axial length \> 26 mm 2. Anisometropia 3. Astigmatism \> 2.00 D 4. Intraocular pressure \> 21 mm Hg or \< 6 mm Hg 5. Active or recent history of severe ocular infection or inflammation 6. Previous incisional or laser surgery 7. Any clinically significant finding on slit lamp biomicroscopy or ophthalmoscopy

Design outcomes

Primary

Measure	Time frame
Change of the cycloplegic spherical equivalent (SE)	from baseline visit to the final visit, up to 52 weeks

Secondary

Measure	Time frame
Change of axial length	from baseline visit to the final visit, up to 52 weeks

Countries

Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026