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

Inclusion criteria

• Signed ICF (Informed Consent Form)
• Subject-reported history of Drye Eye Disease (DED) in both eyes
• Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion criteria

• clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
• Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
• underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
• received or removed permanent lacrimal plug within 3 months before baseline;
• DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction of conjunctival goblet cells;
• ocular or periocular malignancy;
• active ocular allergies, or allergy to the study drug or its components;
• ongoing ocular or systemic infection;
• use of contact lenses within 1 month before screening;
• intraocular surgery or ocular laser surgery within 6 months before enrollment;
• uncontrolled systemic disease or history of herpetic keratitis;
• use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topical anti-glaucoma medication within 60 days before screening;
• used any known oral drugs that could have caused eye dryness within 1 month before screening;
• participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
• inappropriate to participate for other reasons judged by the investigators.