Myopia, ProgressivePhase 2NCT06579287
A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control
A Phase 2 study testing SHJ002 and Atropine in people with Myopia, Progressive, run by Sunhawk Vision Biotech, Inc. at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Myopia, Progressive
- What is being tested?
- SHJ002 and Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 22 Jan 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Taiwan8 sites
Changhua Christian Hospital
Chang-hua
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
Chang Cung Memorial Hospital-Tucheng
New Taipei City, 236
MacKay Memorial Hospital-Tamsui
New Taipei City, 251
Chung Shan Medical University Hospital
Taichung, 402
Cathay General Hospital
Taipei, 106
Taipei Veterans General Hospital
Taipei, 201
Tri-Service General Hospital
Taipei
United States1 site
Pacific Center for Advanced Vision Care Tanasbourne Vision Center
Hillsboro, Ohio, 97124
About this study
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.
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
- Being tested
- SHJ002, Atropine
- Keywords
- Myopia
- Medical subject headings
- Myopia, Degenerative, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHJ002Drug
Topical ophthalmic
AtropineDrug
Topical ophthalmic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the cycloplegic spherical equivalent (SE)
Measured: from baseline visit to the final visit, up to 52 weeks
Secondary outcomes (1)
Change of axial length
Measured: from baseline visit to the final visit, up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start22 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunhawk Vision Biotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579287
- Sponsor's protocol ID
- SHJ002-MY201
- Status last verified
- Jan 2026
- First submitted
- 15 Aug 2024
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06579287
- Acronym / sponsor ID
- SHJ002-MY201
- Conditions
- Myopia, Progressive
- Keywords
- Myopia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sunhawk Vision Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHJ002 | Experimental | Drug: SHJ002The assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks. |
| Atropine | Active comparator | Drug: AtropineThe assigned eyedrops will be instilled in both eyes once per day, one drop per application, 7 days a week, for 52 weeks. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHJ002Topical ophthalmic | Drug | SHJ002 |
| AtropineTopical ophthalmic | Drug | Atropine |
Primary outcome
Change of the cycloplegic spherical equivalent (SE)
Time frame: from baseline visit to the final visit, up to 52 weeks
1 secondary outcome
Change of axial length
Time frame: from baseline visit to the final visit, up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Myopia, Progressive
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
RecruitingPhase 2
Clinical Efficacy and Mechanism Exploration of MR-61 in Delaying the Progression of Myopia
Myopia Progressing
Active, not recruitingPhase 3
MAD Trial: Myopia Atropine Dose
Progressive Myopia
Active, not recruiting
Myopia Control With a Innovative Spectacle Lens - A Cessation Study
Myopia Progressing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHJ002 and Atropine in people with Myopia, Progressive, run by Sunhawk Vision Biotech, Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the cycloplegic spherical equivalent (SE) (time frame: from baseline visit to the final visit, up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.