Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction

• Status: Completed
• Trial end date: 2021-09-07
• Target enrollment: 0
• Participant gender: All

Summary

The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

1. Signed ICF (Informed Consent Form)

2. Subject-reported history of Drye Eye Disease (DED) in both eyes

3. Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

1. clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;

2. Stevens-Johnson syndrome or other severe systemic autoimmune diseases;

3. underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;

4. received or removed permanent lacrimal plug within 3 months before baseline;

5. DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;

6. ocular or periocular malignancy;

7. active ocular allergies, or allergy to the study drug or its components;

8. ongoing ocular or systemic infection;

9. use of contact lenses within 1 month before screening;

10. intraocular surgery or ocular laser surgery within 6 months before enrollment;

11. uncontrolled systemic disease or history of herpetic keratitis;

12. use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;

13. used any known oral drugs that could have caused eye dryness within 1 month before screening;

14. participated in or were participating in other clinical trials drugs or device within 60 days before baseline;

15. inappropriate to participate for other reasons judged by the investigators.