SHJ002 for Near-sightedness

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Sunhawk Vision Biotech, Inc.

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

No Placebo Group

Prior Safety Data

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

+8 more

Exclusion Criteria

Anisometropia

I have had a severe eye infection or inflammation recently.

Intraocular pressure > 21 mm Hg or < 6 mm Hg

+4 more

Trial 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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: SHJ002Experimental Treatment1 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: AtropineActive Control1 Intervention

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