CompletedPhase 2

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

Taiwan116 participantsStarted 2024-06-28

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Change From Baseline to Week 12 in Total Corneal Fluorescein Staining

Timeframe: Baseline to Week 12

Trial details

NCT IDNCT06381986

SponsorSunhawk Vision Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-10

Results submitted2025-07-08

View on ClinicalTrials.gov More Corneal Erosion trials