Corneal ErosionPhase 2NCT06381986
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
A Phase 2 study testing SHJ002 in people with Corneal Erosion, run by Sunhawk Vision Biotech, Inc. at 6 sites in Taiwan.
Trial summary
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients. SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Erosion
- What is being tested?
- SHJ002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 6 sitesTaiwan
- Study dates
- 28 Jun 2024to 17 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
- Diagnosis with Sjogren's syndrome and have corneal erosion
- Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
Who cannot join
- Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED).
- Lid margin disorder other than meibomian gland dysfunction (MGD)
- Presence of any ocular condition
- Any history of eyelid surgery or intraocular/ocular surgery
- Cauterization of the punctum or punctal plug
- Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup
Show all 12Show fewer
- Use of any of the contraindicated drugs medications
- Any changes in the dosing of any chronically used systemic drug
- Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
- Known history of alcohol and/or drug abuse within 12 months
- Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
- Participation in any drug or device clinical investigation within 30 days
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Taiwan6 sites
Kaohsiung Medical Chung-Ho Memorial Hospital
Kaohsiung City, 807
Kaohsiung Veterans General Hospital
Kaohsiung City, 81341
Chang Gung Memorial Hospital-Tu Cheng
New Taipei City, 236
MacKay Memorial Hospital
Taipei, 10449
Cathay General Hospital
Taipei, 106
Tri-Service General Hospital
Taipei, 11490
About this study
Official title: A Clinical Study on the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution in the Treatment of Corneal Erosion in Patients With Sjogren's Syndrome
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
Read the detailed description
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.
- Conditions
- Corneal Erosion
- Being tested
- SHJ002, Vehicle
- Keywords
- Corneal Erosion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHJ002Drug
Topical ophthalmic
VehicleOther
Topical ophthalmic
| Study group | Role | What they receive |
|---|---|---|
| SHJ002 | Experimental | SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks Receives: Drug: SHJ002 |
| Vehicle | Placebo comparator | Vehicle: topically administered to each eye twice daily for 12 weeks Receives: Other: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 12 in Total Corneal Fluorescein Staining
The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).
Measured: Baseline to Week 12
Secondary outcomes (2)
Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)
iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining.
Measured: Baseline to Week 12
Change From Baseline to Week 12 in SANDE Score
Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse symptoms).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start28 Jun 2024
- Primary completion10 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal ErosionStudies 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
- Model description
- Double-Blinded, Parallel, Vehicle-Controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 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
- NCT06381986
- Sponsor's protocol ID
- SHJ002-SJP2
- Status last verified
- Aug 2025
- First submitted
- 12 Apr 2024
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution in the Treatment of Corneal Erosion in Patients With Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT06381986
- Acronym / sponsor ID
- SHJ002-SJP2
- Conditions
- Corneal Erosion
- Keywords
- Corneal Erosion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Sunhawk Vision Biotech, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 24 Apr 2024 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
Detailed description
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-Blinded, Parallel, Vehicle-Controlled
| Arm | Type | Receives |
|---|---|---|
| SHJ002 | Experimental | Drug: SHJ002SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks |
| Vehicle | Placebo comparator | Other: VehicleVehicle: topically administered to each eye twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
- Diagnosis with Sjogren's syndrome and have corneal erosion
- Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
Key exclusion criteria (12 listed)
- Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED).
- Lid margin disorder other than meibomian gland dysfunction (MGD)
- Presence of any ocular condition
- Any history of eyelid surgery or intraocular/ocular surgery
- Cauterization of the punctum or punctal plug
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 |
| VehicleTopical ophthalmic | Other | Vehicle |
Primary outcome
Change From Baseline to Week 12 in Total Corneal Fluorescein Staining
Time frame: Baseline to Week 12
The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).
2 secondary outcomes
Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in SANDE Score
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SHJ002 in people with Corneal Erosion, run by Sunhawk Vision Biotech, Inc. at 6 sites in Taiwan.
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 3 inclusion and 12 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Taiwan. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From Baseline to Week 12 in Total Corneal Fluorescein Staining (time frame: Baseline to Week 12). 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 22 Aug 2025.