Clinical trial NCT05841043: Efficacy and Safety of SHR8028 Eye Drops for the Treatment of Dry Eye Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in total corneal fluorescein staining (tCFS) score (National Eye Institute [NEI] scale) from baseline on Day 29
timeFrame: Baseline, Day 29
measure: Change in eye dryness score (visual analogue scale [VAS] Severity of Dryness) from baseline on Day 29
timeFrame: Baseline, Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: