Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

Phase 2

Completed

• Conditions: Dry Eye Disease
• Interventions: Drug: SHJ002/Vehicle

• Registration Number: NCT05486728
• Lead Sponsor: Dreamhawk Vision Biotech, Inc.

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Study First Posted: 2022-08-04
• Study Start: 2023-02-08
• Status Verified: 2023-12
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
2. Have DED in both eyes for ≥ 6 months
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 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 eye 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHJ002	SHJ002/Vehicle	SHJ002 Ophthalmic Solution will be topically administered to each eye BID for 84 days
Vehicle	SHJ002/Vehicle	Vehicle will be topically administered to each eye BID for 84 days

Primary Outcome Measures

Name	Time	Method
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle	Day 84	change from Baseline in corneal fluorescein staining (CFS) at Final Visit

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED	Day 84	Non-invasive tear break up time (NIBUT)

Trial Locations

Locations (4)

King Chulalongkorn Memorial Hospital; 🇹🇭 Bangkok, Thailand

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung City, Kaohsiung, Taiwan

Australian Eye Specialists; 🇦🇺 Werribee, Victoria, Australia

Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Thailand