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

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

Official Title
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A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction

Conditions
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Treatment of Dry Eye Disease With Meibomian Gland Dysfunction

Intervention / Treatment
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* Drug: SHR8058 eye drops
* Drug: saline eye drops.


Participation Criteria
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Eligibility Criteria
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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.

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
Interventional Model Description: SHR8058 eye drops compared with placebo
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: SHR8058 eye drops<br> | Drug: SHR8058 eye drops<br>* SHR8058 eye drops<br>|
| Placebo Comparator: Treatment group B: saline eye drops<br> | Drug: saline eye drops.<br>* saline eye drops.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 | The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section). | Baseline, Day 57 | 
| Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57 | Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to no dryness and 100% corresponds to maximal dryness). | Baseline, Day 57 |