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

NCT06381986 | Completed Phase 2 Results

• 1 other identifier: SHJ002-SJP2
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 6

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.

Conditions

Corneal Erosion

Keywords

Corneal Erosion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)

  Baseline to Week 12

• Change From Baseline to Week 12 in SANDE Score

  Baseline to Week 12

Study Arms (2)

SHJ002

EXPERIMENTAL

SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks

Drug: SHJ002

Vehicle

PLACEBO COMPARATOR

Vehicle: topically administered to each eye twice daily for 12 weeks

Other: Vehicle

Interventions

SHJ002 DRUG

Topical ophthalmic

SHJ002

Vehicle OTHER

Topical ophthalmic

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunhawk Vision Biotech, Inc.: lead

Study Sites (6)

Kaohsiung Medical Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, 81341, Taiwan

Location

Chang Gung Memorial Hospital-Tu Cheng

New Taipei City, 236, Taiwan

Location

MacKay Memorial Hospital

Taipei, 10449, Taiwan

Location

Cathay General Hospital

Taipei, 106, Taiwan

Location

Tri-Service General Hospital

Taipei, 11490, Taiwan

Location

Results Point of Contact

• Title: President
• Organization: Sunhawk Vision Biotech

hjuo@shvbiotech.com

+886-72222660

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blinded, Parallel, Vehicle-Controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blinded, Parallel, Vehicle-Controlled

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 24, 2024
• Study Start: June 28, 2024
• Primary Completion: April 10, 2025
• Study Completion: April 17, 2025
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (6)