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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Erosion
• Intervention / Treatment: Drug: SHJ002; Other: Vehicle

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 Type: Interventional
• Enrollment (Actual): 116
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical Chung-Ho Memorial Hospital
  • Kaohsiung City, Taiwan, 81341
    • Kaohsiung Veterans General Hospital
  • New Taipei City, Taiwan, 236
    • Chang Gung Memorial Hospital-Tu Cheng
  • Taipei, Taiwan, 106
    • Cathay General Hospital
  • Taipei city, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei city, Taiwan, 11490
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHJ002; SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks	Drug: SHJ002; Topical ophthalmic
Placebo Comparator: Vehicle; Vehicle: topically administered to each eye twice daily for 12 weeks	Other: Vehicle; Topical ophthalmic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	Baseline to Week 12

Collaborators and Investigators

• Sponsor: Sunhawk Vision Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Actual): April 10, 2025
• Study Completion (Actual): April 17, 2025

Study Registration Dates

• First Submitted: April 12, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 5, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Corneal Erosion
• Other Study ID Numbers: SHJ002-SJP2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No