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A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

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.

NCT06579287•Sunhawk Vision Biotech, Inc.

View on ClinicalTrials.gov

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

Age

3 - 12 years

Sex

ALL

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
+1 more criteria

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

Locations (9)

Pacific Center for Advanced Vision Care Tanasbourne Vision Center

Hillsboro, Ohio, United States

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

Key Dates

Start Date

January 22, 2025

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

January 23, 2026

Enrollment

140

ACTUAL participants

Conditions

Myopia, Progressive

Interventions

SHJ002

DRUG

Atropine

DRUG

Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

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Myopia, Progressive

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ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

Low-dose Atropine for Myopia Control in Children

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Myopia, Progressive

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Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

Inclusion Criteria

Exclusion Criteria

Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control

Low-dose Atropine for Myopia Control in Children

Choroidal Response to Novel Spectacle Lens to Control Myopia Progression

Study of OT-101 in Treating Myopia

Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches

Safety, Tolerability and Pharmacodynamics Evaluation of CBT-009 Eye Drop