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

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to placebo in participants with Dry Eye Disease (DED).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dreamhawk Vision Biotech, Inc.

Criteria

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