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

Study Overview
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Brief Summary
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The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease.

Official Title
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A Multi-Center, Randomized, Double-masked, Vehicle-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Drug: SHR8028 eye drops
* Drug: Vehicle eye drops.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR8028 eye drops<br> | Drug: SHR8028 eye drops<br>* SHR8028 eye drops<br>|
| Placebo Comparator: Vehicle<br> | Drug: Vehicle eye drops.<br>* Vehicle eye drops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29 |  | Baseline, Day 29 | 
| Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29 |  | Baseline, Day 29 |