A Multi-Center, Randomized, Double-masked, Vehicle-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country206 target enrollmentMarch 4, 2021

ConditionsDry Eye Disease

InterventionsSHR8028 eye drops Vehicle eye drops.

DrugsSHR8028 eye drops Vehicle eye drops.

Overview

Phase: Phase 3
Intervention: SHR8028 eye drops
Conditions: Dry Eye Disease
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 206
Locations: 1
Primary Endpoint: Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The study is being conducted to assess the efficacy, safety and tolerability of SHR8028 eye drops in comparison to the vehicle for the treatment of dry eye disease.

Registry

clinicaltrials.gov

Start Date

March 4, 2021

End Date

July 22, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 years old;
•Provide written informed consent form;
•Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
•Be currently (within 30 days before visit 0) using over-the-counter (OTC) eye drops, lubricating gels or tear neurostimulator device (such as True TearTM), and/or artificial tears for dry eye symptoms;
•Have at least one eye meets criteria of moderate to severe dry eye both at visit 0\&1
•Be able and willing to follow instructions and participate in all study assessments and visits.

Exclusion Criteria

•Have any clinically significant slit-lamp findings at visit 0 that require treatment with prescription drugs and/or in the opinion of the investigator may interfere with study parameters, such as trauma, Stevens-Johnson syndrome, or advanced epithelial basement membrane disease;
•Have dry eye disease secondary to scar formation, such as radiation, alkali burn, cicatricial pemphigus, and destruction of conjunctival goblet cells (i.e., destruction of conjunctival goblet cells caused by vitamin A deficiency);
•Have active ocular allergy or ocular allergy that may occur during the study;
•Be diagnosed with an ongoing ocular or systemic infection (bacterial, viral, or fungal), including fever, or be undergoing treatment with antibiotics at visit 0 and visit 1;
•Be a woman who is pregnant, breastfeeding, or planning pregnancy;
•Have an uncontrolled systemic disease;
•Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);
•Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;
•Have a condition which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere with the subject's participation in the study significantly;
•Have received or removed lacrimal duct embolism within 90 days before visit 0, or plan to receive or remove lacrimal duct embolism during the study.