Dry Eye Disease Clinical Trial
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
Verified date | April 2023 |
Source | Jiangsu HengRui Medicine Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University Third Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Jiangsu HengRui Medicine Co., Ltd. |
China,
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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