Phase 2
Completed N=116
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
Corneal Erosion
Source: ClinicalTrials.gov NCT06381986 ↗
Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Change From Baseline to Week 12 in Total Corneal Fluorescein Staining — -2.55; -0.37 units on a scale
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.
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 | — |
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
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. Informational only — not medical advice.