Last updated: August 23, 2022
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Completed
Phase
3
Condition
Sjogren's Syndrome
Dry Eye Disease
Blepharitis
Treatment
N/AClinical Study ID
NCT05515471
SHR8058-301
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 studyassessments and visits
Exclusion
Exclusion Criteria:
- clinically significant slit lamp findings or abnormal lid anatomy at screening,including eye trauma, pterygium, active blepharitis, and active lid margininflammation;
- Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
- underwent LipiFlow procedure or intention pulsed light therapy within 6 months beforebaseline, or received Meibomian gland massage treatment within 2 weeks beforebaseline;
- received or removed permanent lacrimal plug within 3 months before baseline;
- DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, ordestruction 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 topicalanti-glaucoma medication within 60 days before screening;
- used any known oral drugs that could have caused eye dryness within 1 month beforescreening;
- 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.
Study Design
Total Participants: 312
Study Start date:
February 04, 2021
Estimated Completion Date:
September 07, 2021
Connect with a study center
Beijing Tongren Hospital
Beijing, Beijing 100730
ChinaSite Not Available

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