Active — Not RecruitingPhase 2

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

United States, Taiwan140 participantsStarted 2025-01-22

Plain-language 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.

Who can participate

Age range3 Years – 12 Years

SexALL

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Inclusion criteria

✓. Be male or female, age 3-12 years (inclusive).
✓. Cycloplegic sphere of -1.00 D or worse in both eyes
✓. Able to complete all study assessments and comply with the protocol
✓. Literate or able to orally communicate.
✓. Parent or guardian able and willing to provide written informed consent
✓. Parent or guardian able and willing to assure subject compliance with the protocol, follow study instructions, and attend study visits
✓. Able to tolerate eye drops in both eyes.
✓. Be able and willing to avoid all disallowed medications and refractive correction

Exclusion criteria

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

What they're measuring

Change of the cycloplegic spherical equivalent (SE)

Timeframe: from baseline visit to the final visit, up to 52 weeks

Trial details

NCT IDNCT06579287

SponsorSunhawk Vision Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Myopia, Progressive trials