A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

Phase 2

Recruiting

• Conditions: Myopia, Progressive
• Interventions: Drug: SHJ002; Drug: Atropine

• Registration Number: NCT06579287
• Lead Sponsor: Sunhawk Vision Biotech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-15
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-30
• Study Start: 2025-01-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-25
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHJ002	SHJ002	The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.
Atropine	Atropine	The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change of axial length	from baseline visit to the final visit, up to 52 weeks

Trial Locations

Locations (7)

Chang Cung Memorial Hospital-Tucheng; 🇨🇳 New Taipei City, Taiwan

MacKay Memorial Hospital-Tamsui; 🇨🇳 New Taipei City, Taiwan

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan

Pacific Center for Advanced Vision Care Tanasbourne Vision Center; 🇺🇸 Hillsboro, Ohio, United States

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan

Cathay General Hospital; 🇨🇳 Taipei City, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan