Using SHJ002 eye drops to control myopia in children

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

This study is testing if SHJ002 eye drops can better control worsening eyesight in children aged 3 to 12 compared to the usual atropine drops.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 3 Years to 12 Years
• Sex: All
• Sponsor: Sunhawk Vision Biotech, Inc. (Industry-sponsored)
• Locations: 8 sites (Hillsboro, Ohio and 7 other locations)
• Trial ID: NCT06579287 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of SHJ002 Sterile Ophthalmic Solution compared to atropine for controlling progressive myopia in children aged 3 to 12 years. Participants will receive either SHJ002 or atropine eye drops and will be monitored for their ability to manage myopia progression. The study aims to determine if SHJ002 can provide a better alternative to existing treatments. The approach involves assessing the impact of an antisense oligonucleotide designed to neutralize a specific microRNA related to myopia.

Who should consider this trial

Good fit: Ideal candidates are children aged 3 to 12 years with a cycloplegic sphere of -1.00 D or worse in both eyes.

Not a fit: Patients who are not within the specified age range or do not have progressive myopia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new, effective option for managing myopia in children, potentially reducing the risk of severe vision problems later in life.

How similar studies have performed: Other studies have shown promise in using similar approaches for myopia control, but the specific use of SHJ002 is novel.

Eligibility criteria

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

Where this trial is running

Hillsboro, Ohio and 7 other locations

• Pacific Center for Advanced Vision Care Tanasbourne Vision Center — Hillsboro, Ohio, United States (Not_yet_recruiting)
• Kaohsiung Veterans General Hospital — Kaohsiung, Taiwan (Recruiting)
• Chang Cung Memorial Hospital-Tucheng — New Taipei City, Taiwan (Recruiting)
• MacKay Memorial Hospital-Tamsui — New Taipei City, Taiwan (Recruiting)
• Chung Shan Medical University Hospital — Taichung, Taiwan (Recruiting)
• Cathay General Hospital — Taipei City, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei City, Taiwan (Recruiting)
• Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Suh-Hang H. Juo, MD, Ph.D.

Conditions Myopia, Progressive; Myopia