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Active, not recruiting Phase 2

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

NCT06579287 · tracked via the Priya Life Science USA tracker
Sponsor
Sunhawk Vision Biotech, Inc
Phase
Phase 2
Started
2025-01-22
Last updated
2026-01-23

Condition(s) studied

Myopia, Progressive

Investigational drug(s) / intervention(s)

SHJ002Atropine →

SHJ002: Topical ophthalmic

Atropine: Topical ophthalmic

Study 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.

Eligibility

Sex
ALL
Min age
3 Years
Max age
12 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change of the cycloplegic spherical equivalent (SE) — from baseline visit to the final visit, up to 52 weeks

Trial sites (9)

FacilityCityRegionStatus
Pacific Center for Advanced Vision Care Tanasbourne Vision Center Hillsboro Ohio
Changhua Christian Hospital Chang-hua Taiwan
Kaohsiung Veterans General Hospital Kaohsiung City Taiwan
Chang Cung Memorial Hospital-Tucheng New Taipei City Taiwan
MacKay Memorial Hospital-Tamsui New Taipei City Taiwan
Chung Shan Medical University Hospital Taichung Taiwan
Cathay General Hospital Taipei Taiwan
Taipei Veterans General Hospital Taipei Taiwan
Tri-Service General Hospital Taipei Taiwan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06579287 on ClinicalTrials.gov ↗ ← All trials in the USA