Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients

Phase 2

Completed

• Conditions: Corneal Erosion
• Interventions: Drug: SHJ002; Other: Vehicle

• 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.

Study Timeline

• Study First Submitted: 2024-04-12
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-24
• Study Start: 2024-06-28
• Primary Completion: 2025-04-10
• Study Completion: 2025-04-17
• Results First Submitted: 2025-07-08
• Status Verified: 2025-08
• Results First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Results First Posted: 2025-08-22
• Last Update Posted: 2025-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
2. Diagnosis with Sjogren's syndrome and have corneal erosion
3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test

Exclusion Criteria

1. Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED).
2. Lid margin disorder other than meibomian gland dysfunction (MGD)
3. Presence of any ocular condition
4. Any history of eyelid surgery or intraocular/ocular surgery
5. Cauterization of the punctum or punctal plug
6. Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup
7. Use of any of the contraindicated drugs medications
8. Any changes in the dosing of any chronically used systemic drug
9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
10. Known history of alcohol and/or drug abuse within 12 months
11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
12. 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: topically administered to each eye twice daily for 12 weeks
Vehicle	Vehicle	Vehicle: topically administered to each eye twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Total Corneal Fluorescein Staining	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)	Baseline to Week 12	iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining.
Change From Baseline to Week 12 in SANDE Score	Baseline to Week 12	Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse 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