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

NCT05486728 | Completed Phase 2 Results

• 1 other identifier: SHJ002-DED2203
• Study Type: interventional
• Target: 85
• Locations: 3 countries
• Sites: 4

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.

Conditions

Dry Eye Disease

Keywords

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)

  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).

  Baseline and Day 84

Secondary Outcomes (2)

• Change From Baseline in SANDE Score

  Baseline and Day 84

• Change From Baseline in Eye Dryness Score (Visual Analogue Scale)

  Baseline and Day 84

Study Arms (2)

SHJ002

EXPERIMENTAL

SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days

Drug: SHJ002/Vehicle

Vehicle

PLACEBO COMPARATOR

Vehicle: topically administered to each eye BID for 84 days

Drug: SHJ002/Vehicle

Interventions

SHJ002/Vehicle DRUG

Topical ophthalmic

SHJ002; Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dreamhawk Vision Biotech, Inc.: lead

Study Sites (4)

Australian Eye Specialists

Werribee, Victoria, 3030, Australia

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Kaohsiung, 813414, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, 10330, Thailand

Location

Ramathibodi Hospital, Mahidol University

Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: President
• Organization: Sunhawk Vision Biotech

hjuo@shvbiotech.com

+886-7-2222660

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Double-Blinded, Parallel, Vehicle-Controlled

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 4, 2022
• Study Start: February 8, 2023
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: October 14, 2025
• Results First Posted: October 14, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); TH (2); TW (1)