A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

Sunhawk Vision Biotech

Status and phase: Enrolling; Phase 2

Conditions: Myopia, Progressive

Treatments: Drug: SHJ002; Drug: Atropine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06579287

SHJ002-MY201

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

144 participants in 2 patient groups

SHJ002

Experimental group

Description:

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

Treatment:

Drug: SHJ002

Atropine

Active Comparator group

Description:

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

Treatment:

Drug: Atropine