Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: SHR8028 eye drops; Drug: Vehicle eye drops.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Provide written informed consent form;
3. Have a subject reported history of dry eye disease in both eyes for at least 180 days before the screening visit (visit 0);
4. 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;
5. Have at least one eye meets criteria of moderate to severe dry eye both at visit 0&1
6. Be able and willing to follow instructions and participate in all study assessments and visits.

Exclusion Criteria:

1. 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;
2. 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);
3. Have active ocular allergy or ocular allergy that may occur during the study;
4. 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;
5. Be a woman who is pregnant, breastfeeding, or planning pregnancy;
6. Have an uncontrolled systemic disease;
7. Have allergies to investigational medicinal product (IMP) or its components: cyclosporin A or semi-fluorinated alkanes (SFA);
8. Be currently participating in other drug or device trials, or have used other investigational drugs or devices within 60 days before visit 0;
9. 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;
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: Vehicle eye drops.; Vehicle eye drops.
Experimental: SHR8028 eye drops	Drug: SHR8028 eye drops; SHR8028 eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29	Baseline, Day 29
Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29	Baseline, Day 29

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Actual): April 2, 2022
• Study Completion (Actual): July 22, 2022

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: SHR8028-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No