Status:
RECRUITING
A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control
Lead Sponsor:
Sunhawk Vision Biotech, Inc.
Conditions:
Myopia, Progressive
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT06579287
Start Date
January 22 2025
End Date
April 1 2026
Last Update
June 6 2025
Active Locations (9)
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1
Pacific Center for Advanced Vision Care Tanasbourne Vision Center
Hillsboro, Ohio, United States, 97124
2
Changhua Christian Hospital
Chang-hua, Taiwan
3
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan, 813
4
Chang Cung Memorial Hospital-Tucheng
New Taipei City, Taiwan, 236