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

A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: SHJ002/Vehicle

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 Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Werribee, Victoria, Australia, 3030
      • Australian Eye Specialists
• Taiwan
  • Kaohsiung
    • Kaohsiung City, Kaohsiung, Taiwan, 813414
      • Kaohsiung Veterans General Hospital
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Memorial Hospital
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHJ002; SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days	Drug: SHJ002/Vehicle; Topical ophthalmic
Placebo Comparator: Vehicle; Vehicle: topically administered to each eye BID for 84 days	Drug: SHJ002/Vehicle; Topical ophthalmic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in SANDE Score	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).	Baseline and Day 84
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)	100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.	Baseline and Day 84

Collaborators and Investigators

• Sponsor: Dreamhawk Vision Biotech, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 4, 2022

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Dry Eye Disease
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: SHJ002-DED2203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No