ACTIVE_NOT_RECRUITING

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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.

Quick Facts

Study Start:2025-01-22

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06579287

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.

Ages Eligible for Study:3 Years to 12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Locations (Sites)

Pacific Center for Advanced Vision Care Tanasbourne Vision Center

Hillsboro, Ohio, 97124

United States

Collaborators and Investigators

Sponsor: Sunhawk Vision Biotech, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-22

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-01-22

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

Myopia

Additional Relevant MeSH Terms

Myopia, Progressive