NCT06381986CompletedPhase 2
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
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
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- First submitted
- 12 Apr 2024
- Start date
- 28 Jun 2024
- Primary completion date
- 10 Apr 2025
- Lead sponsor
- Sunhawk Vision Biotech, Inc.
- Diseases
- Sjögren's disease
- NCT number
- NCT06381986
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 116
- From 28 Jun 2024 to the primary completion date, 10 Apr 2025
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any of the contraindicated drugs medications
- Any changes in the dosing of any chronically used systemic drug
- 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
Other illness
- 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
- 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
Other
- Cauterization of the punctum or punctal plug
- Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kaohsiung Veterans General Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital-Tu Cheng Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Cathay General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.