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

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: SHJ002/Vehicle

• Registration Number: NCT05486728
• Lead Sponsor: Dreamhawk Vision Biotech, Inc.

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.

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2023-02-08
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Results First Submitted: 2025-06-16
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Results First Posted: 2025-10-14
• Last Update Posted: 2025-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
2. Have DED in both eyes for ≥ 6 months
3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test

Exclusion Criteria

1. Ocular surface corneal disease, other than DED.
2. Lid margin disorder other than meibomian gland dysfunction (MGD)
3. Presence of any ocular condition
4. Any history of eyelid surgery or intraocular/ocular surgery
5. Cauterization of the punctum or punctal plug
6. Use of lid scrubs containing chemicals or baby shampoo, or eye makeup
7. Use of any of the contraindicated drugs medications
8. Any changes in the dosing of any chronically used systemic drug
9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
10. Known history of alcohol and/or drug abuse within 12 months
11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents.
12. Participation in any drug or device clinical investigation within 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHJ002	SHJ002/Vehicle	SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
Vehicle	SHJ002/Vehicle	Vehicle: topically administered to each eye BID for 84 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)	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 Outcome Measures

Name	Time	Method
Change From Baseline in SANDE Score	Baseline and Day 84	The SANDE questionnaire assesses dry eye symptoms on a scale from 0 (no symptoms) to 100 (worst symptoms). The reported values represent change from baseline to Day 84 (Day 84 - Baseline).
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)	Baseline and Day 84	100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.

Trial Locations

Locations (4)

Australian Eye Specialists; 🇦🇺 Werribee, Victoria, Australia

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Kaohsiung, Taiwan

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand