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

Corneal Erosion Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06381986
• Other study ID #: SHJ002-SJP2
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Corneal Erosion

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