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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Drug: SHJ002; Drug: Atropine

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Chang-hua, Taiwan
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 813
    • Kaohsiung Veterans General Hospital
  • New Taipei City, Taiwan, 236
    • Chang Cung Memorial Hospital-Tucheng
  • New Taipei City, Taiwan, 251
    • MacKay Memorial Hospital-Tamsui
  • Taichung, Taiwan, 402
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan, 106
    • Cathay General Hospital
  • Taipei, Taiwan, 201
    • Taipei Veterans General Hospital
• United States
  • Ohio
    • Hillsboro, Ohio, United States, 97124
      • Pacific Center for Advanced Vision Care Tanasbourne Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHJ002; The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.	Drug: SHJ002; Topical ophthalmic
Active Comparator: Atropine; The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.	Drug: Atropine; Topical ophthalmic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sunhawk Vision Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 15, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Myopia
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative; Organic Chemicals; Heterocyclic Compounds; Alkaloids; Aza Compounds; Heterocyclic Compounds, Bridged-Ring; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Atropine
• Other Study ID Numbers: SHJ002-MY201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No