CompletedPhase 2

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

Australia, Taiwan, Thailand85 participantsStarted 2023-02-08

Plain-language summary

The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). 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.
✓. Have DED in both eyes for ≥ 6 months
✓. 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 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 eye 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 in Total Corneal Fluorescein Staining (NEI Scale)

Timeframe: Baseline and Day 84

Trial details

NCT IDNCT05486728

SponsorDreamhawk Vision Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-07

Results submitted2025-06-16

View on ClinicalTrials.gov More Dry Eye Disease trials