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

Last updated: August 5, 2025
Sponsor: Sunhawk Vision Biotech, Inc.
Overall Status: Completed

Phase

2

Condition

N/A

Treatment

SHJ002

Vehicle

Clinical Study ID

NCT06381986
SHJ002-SJP2
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female participants 18 years of age or older inclusive, at the time ofsigning the informed consent.

  2. Diagnosis with Sjogren's syndrome and have corneal erosion

  3. Female participants must be 1 year postmenopausal, surgically sterilized, or femalesof childbearing potential with a negative urine pregnancy test

Exclusion

Exclusion Criteria:

  1. Ocular surface corneal disease, other than corneal erosion and dry eye disease (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 eyelid 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 confoundstudy 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

Total Participants: 116
Treatment Group(s): 2
Primary Treatment: SHJ002
Phase: 2
Study Start date:
June 28, 2024
Estimated Completion Date:
April 17, 2025

Study Description

Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.

Connect with a study center

  • Kaohsiung Medical Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 81341
    Taiwan

    Site Not Available

  • Kaohsiung Medical Chung-Ho Memorial Hospital

    Kaohsiung City 1673820, 807
    Taiwan

    Site Not Available

  • Kaohsiung Veterans General Hospital

    Kaohsiung City 1673820, 81341
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital-Tu Cheng

    New Taipei City, 236
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital-Tu Cheng

    New Taipei City 12908892, 236
    Taiwan

    Site Not Available

  • Cathay General Hospital

    Taipei, 106
    Taiwan

    Site Not Available

  • Cathay General Hospital

    Taipei 1668341, 106
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital

    Taipei 1668341, 10449
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei 1668341, 11490
    Taiwan

    Site Not Available

  • MacKay Memorial Hospital

    Taipei city, 10449
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei city, 11490
    Taiwan

    Site Not Available

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