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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05841043
Other study ID # SHR8028-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 4, 2021
Est. completion date July 22, 2022

Study information

Verified date April 2023
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date July 22, 2022
Est. primary completion date April 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
SHR8028 eye drops
SHR8028 eye drops
Vehicle eye drops.
Vehicle eye drops.

Locations

Country Name City State
China Peking University Third Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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