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

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Treatment of Dry Eye Disease With Meibomian Gland Dysfunction

Treatments: Drug: saline eye drops.; Drug: SHR8058 eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT05515471

SHR8058-301

Details and patient eligibility

About

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

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 study assessments and visits

Exclusion criteria

1. clinically significant slit lamp findings or abnormal lid anatomy at screening, including eye trauma, pterygium, active blepharitis, and active lid margin inflammation;
2. Stevens-Johnson syndrome or other severe systemic autoimmune diseases;
3. underwent LipiFlow procedure or intention pulsed light therapy within 6 months before baseline, or received Meibomian gland massage treatment within 2 weeks before baseline;
4. received or removed permanent lacrimal plug within 3 months before baseline;
5. DED secondary to scarring, radiation, alkali burns, cicatricial pemphigoid, or destruction 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 topical anti-glaucoma medication within 60 days before screening;
13. used any known oral drugs that could have caused eye dryness within 1 month before screening;
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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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312 participants in 2 patient groups, including a placebo group

Treatment group A: SHR8058 eye drops

Experimental group

Treatment:

Drug: SHR8058 eye drops

Treatment group B: saline eye drops

Placebo Comparator group

Treatment:

Drug: saline eye drops.