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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-04

Study Completion Date

2021-09-07

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.

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Detailed Description

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Conditions

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Treatment of Dry Eye Disease With Meibomian Gland Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

SHR8058 eye drops compared with placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Treatment group A: SHR8058 eye drops

Group Type EXPERIMENTAL

SHR8058 eye drops

Intervention Type DRUG

SHR8058 eye drops

Treatment group B: saline eye drops

Group Type PLACEBO_COMPARATOR

saline eye drops.

Intervention Type DRUG

saline eye drops.

Interventions

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SHR8058 eye drops

Intervention Type DRUG

saline eye drops.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No