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Completed

NCT Number: NCT05486728

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle 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.

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Key information

Conditions

Dry Eye Disease Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Australian Eye Specialists, Werribee, Victoria, Australia

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About this study

Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHJ002/Vehicle

Drug

Topical ophthalmic

Primary outcomes

  1. 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

  1. Change From Baseline in SANDE Score

    Time frame: 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).

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dreamhawk Vision Biotech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 4, 2022
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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