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

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/A

Clinical Study ID

NCT05515471
SHR8058-301
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed ICF (Informed Consent Form)
  2. Subject-reported history of Drye Eye Disease (DED) in both eyes
  3. Ability and willingness to follow instructions, including participation in all studyassessments and visits

Exclusion

Exclusion Criteria:

  1. clinically significant slit lamp findings or abnormal lid anatomy at screening,including eye trauma, pterygium, active blepharitis, and active lid margininflammation;
  2. Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
  3. underwent LipiFlow procedure or intention pulsed light therapy within 6 months beforebaseline, or received Meibomian gland massage treatment within 2 weeks beforebaseline;
  4. received or removed permanent lacrimal plug within 3 months before baseline;
  5. DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, ordestruction of conjunctival goblet cells;
  6. ocular or periocular malignancy;
  7. active ocular allergies, or allergy to the study drug or its components;
  8. ongoing ocular or systemic infection;
  9. use of contact lenses within 1 month before screening;
  10. intraocular surgery or ocular laser surgery within 6 months before enrollment;
  11. uncontrolled systemic disease or history of herpetic keratitis;
  12. use of topical steroids, topical cyclosporine, lifitegrast, serum tears, or topicalanti-glaucoma medication within 60 days before screening;
  13. used any known oral drugs that could have caused eye dryness within 1 month beforescreening;
  14. participated in or were participating in other clinical trials drugs or device within 60 days before baseline;
  15. 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
    China

    Site Not Available

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