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

Launched by JIANGSU HENGRUI MEDICINE CO., LTD. · Aug 23, 2022

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Eligibility 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.