A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
Overview
- Phase
- Phase 2
- Intervention
- SHJ002/Vehicle
- Conditions
- Dry Eye Disease
- Sponsor
- Dreamhawk Vision Biotech, Inc.
- Enrollment
- 85
- Locations
- 4
- Primary Endpoint
- Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief 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.
Detailed Description
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.
Investigators
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
Arms & Interventions
SHJ002
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
Intervention: SHJ002/Vehicle
Vehicle
Vehicle: topically administered to each eye BID for 84 days
Intervention: SHJ002/Vehicle
Outcomes
Primary Outcomes
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
Time Frame: Baseline and Day 84
NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3).
Secondary Outcomes
- Change From Baseline in SANDE Score(Baseline and Day 84)
- Change From Baseline in Eye Dryness Score (Visual Analogue Scale)(Baseline and Day 84)