SHJ002 for Near-sightedness

Recruiting at 7 trial locations

Overseen By Suh-Hang H. Juo, MD, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Sunhawk Vision Biotech, Inc.

Disqualifiers: Axial length > 26 mm, Anisometropia, Astigmatism > 2.00 D, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but you must avoid all disallowed medications and refractive correction. It's best to discuss your current medications with the trial team.

Eligibility Criteria

This trial is for individuals with near-sightedness, particularly those whose myopia is worsening (degenerative or progressive). Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to have a specific level of myopia.

Inclusion Criteria

Literate or able to orally communicate

Parent or guardian able and willing to provide written informed consent

For female subjects of childbearing potential, a negative urinary test

Exclusion Criteria

Anisometropia

I have had a severe eye infection or inflammation recently.

Intraocular pressure > 21 mm Hg or < 6 mm Hg

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive SHJ002 or Atropine eyedrops once daily for myopia control

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SHJ002

Trial Overview The study tests the safety and effectiveness of SHJ002 Sterile Ophthalmic Solution compared to atropine in controlling myopia. SHJ002 is designed to target a microRNA related to eye growth.

Participant Groups

Group I: SHJ002 Experimental Treatment 1 Intervention

The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.

Group II: Atropine Active Control 1 Intervention

The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks.

Who Is Running the Clinical Trial?

Sunhawk Vision Biotech, Inc.

Lead Sponsor

Trials

3

Recruited

280+