NCT06579287

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_2

Timeline
7mo left

Started Jan 2025

Geographic Reach
2 countries

9 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

August 15, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

January 22, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1.9 years

First QC Date

August 15, 2024

Last Update Submit

January 21, 2026

Conditions

Myopia, Progressive

Keywords

Myopia

Outcome Measures

Primary Outcomes (1)

  • Change of the cycloplegic spherical equivalent (SE)

    from baseline visit to the final visit, up to 52 weeks

Secondary Outcomes (1)

  • Change of axial length

    from baseline visit to the final visit, up to 52 weeks

Study Arms (2)

SHJ002

EXPERIMENTAL

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

Drug: SHJ002

Atropine

ACTIVE COMPARATOR

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

Drug: Atropine

Interventions

SHJ002DRUG

Topical ophthalmic

SHJ002
AtropineDRUG

Topical ophthalmic

Atropine

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Pacific Center for Advanced Vision Care Tanasbourne Vision Center

Hillsboro, Ohio, 97124, United States

Location

Changhua Christian Hospital

Chang-hua, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

Location

Chang Cung Memorial Hospital-Tucheng

New Taipei City, 236, Taiwan

Location

MacKay Memorial Hospital-Tamsui

New Taipei City, 251, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 402, Taiwan

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 201, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Myopia, DegenerativeMyopia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Intervention Hierarchy (Ancestors)

Atropine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsBelladonna AlkaloidsSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 30, 2024

Study Start

January 22, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)TW(8)