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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06381986
Other study ID # SHJ002-SJP2
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date May 2024
Est. completion date February 2025

Study information

Verified date April 2024
Source Sunhawk Vision Biotech, Inc.
Contact Suh-Hang H. Juo, MD, Ph.D.
Phone +886-975357586
Email hjuo@shvbiotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 122
Est. completion date February 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent. 2. Diagnosis with Sjogren's syndrome and have corneal erosion 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 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 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


Related Conditions & MeSH terms


Intervention

Drug:
SHJ002
Topical ophthalmic
Other:
Vehicle
Topical ophthalmic

Locations

Country Name City State
Taiwan Kaohsiung Medical Chung-Ho Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Sunhawk Vision Biotech, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score Change from Baseline in corneal fluorescein staining (CFS) score week 12
Secondary To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score Change from Baseline in central corneal fluorescein staining (cCFS) score week 12
Secondary To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) Visual Analogue Scale (VAS)
100-mm horizontal scale, filled in by participant on the horizontal line from 0 (no discomfort) to 100 (maximal discomfort).
week 12
Secondary To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) Symptom Assessment in Dry Eye (SANDE)
The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms
week 12
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