A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

Description

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.

Conditions

Myopia, Progressive

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Study Overview

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Study Details

Study overview

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.

A Phase II Study to Determine the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution on Myopia Control in Subjects Aged 3-12 Years.

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

Condition
Myopia, Progressive
Intervention / Treatment

-

Contacts and Locations

Hillsboro

Pacific Center for Advanced Vision Care Tanasbourne Vision Center, Hillsboro, Ohio, United States, 97124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

3 Years to 12 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sunhawk Vision Biotech, Inc.,

Study Record Dates

2026-04