A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of SHR8058 on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction
Overview
- Phase
- Phase 3
- Intervention
- SHR8058 eye drops
- Conditions
- Treatment of Dry Eye Disease With Meibomian Gland Dysfunction
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 312
- Locations
- 1
- Primary Endpoint
- Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.
Investigators
Eligibility 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;
Arms & Interventions
Treatment group A: SHR8058 eye drops
Intervention: SHR8058 eye drops
Treatment group B: saline eye drops
Intervention: saline eye drops.
Outcomes
Primary Outcomes
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
Time Frame: 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
Time Frame: 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").