Phase 2
N=85
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT05486728 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) — -2.4; -1.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SHJ002/Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dreamhawk Vision Biotech, Inc.
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) |
-2.4; -1.3 | — |
| SECONDARY Change From Baseline in SANDE Score |
-43.9; -36.0 | — |
| SECONDARY Change From Baseline in Eye Dryness Score (Visual Analogue Scale) |
-32.0; -23.3 | — |
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.
Eligibility Criteria
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
- 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 (NCT05486728). 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.