This website uses cookies to enhance your browsing experience, improve site performance, and gather analytics. By selecting 'Accept,' you consent to these cookies as described in our Privacy Policy.

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

Sponsored by Dreamhawk Vision Biotech, Inc.

About this trial

Last updated 2 years ago

Study ID

SHJ002-DED2203

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Completed