Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease

Inclusion criteria

• Age ≥ 18 years old;
• Provide written informed consent form;
• Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
• Be currently (within 30 days before visit 0) using over-the-counter (OTC) eye drops, lubricating gels or tear neurostimulator device (such as True TearTM), and/or artificial tears for dry eye symptoms;
• Have at least one eye meets criteria of moderate to severe dry eye both at visit 0&1
• Be able and willing to follow instructions and participate in all study assessments and visits.

Exclusion criteria

• Have any clinically significant slit-lamp findings at visit 0 that require treatment with prescription drugs and/or in the opinion of the investigator may interfere with study parameters, such as trauma, Stevens-Johnson syndrome, or advanced epithelial basement membrane disease;
• Have dry eye disease secondary to scar formation, such as radiation, alkali burn, cicatricial pemphigus, and destruction of conjunctival goblet cells (i.e., destruction of conjunctival goblet cells caused by vitamin A deficiency);
• Have active ocular allergy or ocular allergy that may occur during the study;
• Be diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or be undergoing treatment with antibiotics at visit 0 and visit 1;
• Be a woman who is pregnant, breastfeeding, or planning pregnancy;
• Have an uncontrolled systemic disease;
• Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);
• Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;
• Have a condition which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere with the subject's participation in the study significantly;
• Have received or removed lacrimal duct embolism within 90 days before visit 0, or plan to receive or remove lacrimal duct embolism during the study.