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Completed

NCT Number: NCT06381986

Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients

The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.

SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.

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Key information

Conditions

Corneal Erosion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kaohsiung Medical Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan

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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 twice daily for 12 weeks.

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.
  • Diagnosis with Sjogren's syndrome and have corneal erosion
  • 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 corneal erosion and dry eye disease (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 eyelid 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

Drug

Topical ophthalmic

Vehicle

Other

Topical ophthalmic

Primary outcomes

  1. Change From Baseline to Week 12 in Total Corneal Fluorescein Staining

    Time frame: Baseline to Week 12

    The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).

Secondary outcomes

  1. Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)

    Time frame: Baseline to Week 12

    iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining.

  2. Change From Baseline to Week 12 in SANDE Score

    Time frame: Baseline to Week 12

    Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse symptoms).

Sponsors and collaborators

Lead sponsor

Sunhawk Vision Biotech, Inc.

Industry

Registry information

Official study title

A Clinical Study on the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution in the Treatment of Corneal Erosion in Patients With Sjogren's Syndrome

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
Aug 22, 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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