Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
- Registration Number
- NCT06381986
- Lead Sponsor
- Sunhawk Vision Biotech, Inc.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SHJ002 SHJ002 SHJ002 Ophthalmic Solution will be topically administered to each eye twice daily for 12 weeks Vehicle Vehicle Vehicle will be topically administered to each eye twice daily for 12 weeks
- Primary Outcome Measures
Name Time Method To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score week 12 Change from Baseline in corneal fluorescein staining (CFS) score
- Secondary Outcome Measures
Name Time Method To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score week 12 Change from Baseline in central corneal fluorescein staining (cCFS) score
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) week 12 Visual Analogue Scale (VAS)
100-mm horizontal scale, filled in by participant on the horizontal line from 0 (no discomfort) to 100 (maximal discomfort).To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) week 12 Symptom Assessment in Dry Eye (SANDE)
The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms
Trial Locations
- Locations (6)
Chang Gung Memorial Hospital-Tu Cheng
🇨🇳New Taipei City, Taiwan
Cathay General Hospital
🇨🇳Taipei, Taiwan
Kaohsiung Veterans General Hospital
🇨🇳Kaohsiung City, Taiwan
Kaohsiung Medical Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
MacKay Memorial Hospital
🇨🇳Taipei city, Taiwan
Tri-Service General Hospital
🇨🇳Taipei city, Taiwan