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.
Eligibility
Sex
ALL
Min age
3 Years
Max age
12 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change of the cycloplegic spherical equivalent (SE) — from baseline visit to the final visit, up to 52 weeks
Trial sites (9)
Facility
City
Region
Status
Pacific Center for Advanced Vision Care Tanasbourne Vision Center
Hillsboro
Ohio
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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