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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
Kaohsiung Medical Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital-Tu Cheng
New Taipei City, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
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).
Time frame: Baseline to Week 12
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.
Time frame: 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).
Time frame: Baseline to Week 12
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Cathay General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan