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OpenTrials
Active, Not Recruiting

NCT Number: NCT06579287

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myopia, Progressive Eye Diseases Myopia Myopia, Degenerative Refractive Errors

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Changhua Christian Hospital, Chang-hua, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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.
  • Women of childbearing potential must agree to use two reliable methods of contraception
  • 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

  • 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

Treatment and study plan

SHJ002

Drug

Topical ophthalmic

Atropine

Drug

Topical ophthalmic

Primary outcomes

  1. Change of the cycloplegic spherical equivalent (SE)

    Time frame: from baseline visit to the final visit, up to 52 weeks

Secondary outcomes

  1. Change of axial length

    Time frame: from baseline visit to the final visit, up to 52 weeks

Sponsors and collaborators

Lead sponsor

Sunhawk Vision Biotech, Inc.

Industry

Registry information

Official study title

A Phase II Study to Determine the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution on Myopia Control in Subjects Aged 3-12 Years.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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