A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control
Running, not enrolling · Phase 2
Conditions studied: Myopia, Progressive
In brief
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.
Key facts
- Study ID
- NCT06579287
- Run by
- Sunhawk Vision Biotech, Inc.
- People needed
- 140
- Starts
- 2025-01-22
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-23
Who can join
Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Pacific Center for Advanced Vision Care Tanasbourne Vision Center — Hillsboro, Ohio, United States
- Changhua Christian Hospital — Chang-hua, Taiwan
- Kaohsiung Veterans General Hospital — Kaohsiung City, Taiwan
- Chang Cung Memorial Hospital-Tucheng — New Taipei City, Taiwan
- MacKay Memorial Hospital-Tamsui — New Taipei City, Taiwan
- Chung Shan Medical University Hospital — Taichung, Taiwan
- Cathay General Hospital — Taipei, Taiwan
- Taipei Veterans General Hospital — Taipei, Taiwan
- Tri-Service General Hospital — Taipei, Taiwan
Full record on ClinicalTrials.gov
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