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

Dry Eye Disease Clinical Trial

Official title:

A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05486728
• Other study ID #: SHJ002-DED2203
• Status: Completed
• Phase: Phase 2
• Start date: February 8, 2023
• Est. completion date: December 7, 2023

Study information

• Verified date: December 2023
• Source: Dreamhawk Vision Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• 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. 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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• SHJ002/Vehicle
Topical ophthalmic

Locations

Country	Name	City	State
Australia	Australian Eye Specialists	Werribee	Victoria
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City	Kaohsiung
Thailand	King Chulalongkorn Memorial Hospital	Bangkok
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Dreamhawk Vision Biotech, Inc.

Countries where clinical trial is conducted

Australia,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle	change from Baseline in corneal fluorescein staining (CFS) at Final Visit	Day 84
Secondary	To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED	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	Day 84
Secondary	To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED	Conjunctival hyperemia; The reference scale consists of 6 levels or grades of conjunctival hyperemia (0 = none, 5 = severe)	Day 84
Secondary	To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED	Eye dryness / Visual Analogue Scale (VAS); 100-mm horizontal scale, filled in by participant on the horizontal line from 0 (no discomfort) to 100 (maximal discomfort).	Day 84
Secondary	To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measure by signs and symptoms of DED	Non-invasive tear break up time (NIBUT)	Day 84