Phase 2 N=116 Randomized Quadruple-blind Treatment

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

Corneal Erosion

Bottom Line

View on ClinicalTrials.gov: NCT06381986 ↗

Enrolled (actual)

116

Serious AEs

0.0%

Results posted

Aug 2025

Primary outcome: Primary: Change From Baseline to Week 12 in Total Corneal Fluorescein Staining — -2.55; -0.37 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SHJ002 (Drug); Vehicle (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sunhawk Vision Biotech, Inc.
Primary completion: Apr 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline to Week 12 in Total Corneal Fluorescein Staining	-2.55; -0.37	—
SECONDARY Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)	-0.79; -0.14	—
SECONDARY Change From Baseline to Week 12 in SANDE Score	-31.21; -28.87	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06381986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.