Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
Study Details
Study Description
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group A: SHR8058 eye drops
|
Drug: SHR8058 eye drops
SHR8058 eye drops
|
| Placebo Comparator: Treatment group B: saline eye drops
|
Drug: saline eye drops.
saline eye drops.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57 [Baseline, 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).
- Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57 [Baseline, 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").
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tongren Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR8058-301