Clinical trial NCT06579287: A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control
Official title: A Phase II Study to Determine the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution on Myopia Control in Subjects Aged 3-12 Years.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Myopia, Progressive
Keywords: Myopia
Lead sponsor: Sunhawk Vision Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-30
Enrollment: 144
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 specific microRNA.


Eligibility criteria: 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 outcomes:
measure: Change of the cycloplegic spherical equivalent (SE)
timeFrame: from baseline visit to the final visit, up to 52 weeks
Secondary outcomes:
measure: Change of axial length
timeFrame: from baseline visit to the final visit, up to 52 weeks
Other outcomes:
Locations:
city: Hillsboro
country: United States
facility: Pacific Center for Advanced Vision Care Tanasbourne Vision Center
state: Ohio
city: Chang Hua
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: New Taipei City
country: Taiwan
facility: Chang Cung Memorial Hospital-Tucheng
city: New Taipei City
country: Taiwan
facility: MacKay Memorial Hospital-Tamsui
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei City
country: Taiwan
facility: Cathay General Hospital
city: Taipei city
country: Taiwan
facility: Tri-Service General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: