Dry Eye Disease
Conditions
Interventions
Experimental drug:Lifitegrast Ophthalmic Solution
placebo:Vehicle for Lifitegrast Ophthalmic Solution
Sponsors
Eye & ENT Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Those who voluntarily participate and sign the informed consent form are willing to abide by the treatment arrangements stipulated in the trial protocol and are willing to follow up on time. 2.Age >=18 years old, gender not limited. 3.During the screening period visit (the first visit), the living visual acuity of both eyes was 4.5 or better on the standard logarithmic visual acuity chart (i.e., standard logarithmic visual acuity>=4.5). 4.Those diagnosed with dry eye according to the diagnostic criteria of the "Chinese Expert Consensus on Dry Eye (2020 Edition)". 5.During the screening period visits and baseline period visits (the first and second visits), the corneal fluorescein staining score of at least one eye and any one area of the same eye was >=2. 6.During the screening period visits and the baseline period visits (the first and second visits), at least one eye and the conjunctival congestion score of the same eye was >=1. 7.During the screening period visits and the baseline period visits (the first and second visits), at least one eye and the same eye simultaneously met the following two criteria. (1)The lower corneal fluorescein staining score (ICSS) is>=0.5. (2)Schirmer tear Test (STT; (No anesthesia)>=1mm and <=10mm.
Exclusion criteria
Exclusion criteria: 1. Currently suffering from ocular herpes or any other ocular infection or inflammation, or having a history of ocular herpes or any other ocular infection within 30 days prior to screening. 2. Suffering from ocular diseases such as abnormal eyelid margin structure (ectropion, entropion, eyelid relaxation, etc.), severe conjunctival relaxation, Salzmann nodular corneal degeneration, damage to conjunctival goblet cells (such as vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), diabetic retinopathy, retinal vein occlusion, etc. And those whose researchers believe that the disease may increase the risk of the subjects or may affect the results of the trial. 3. Those who have used anti-glaucoma drugs within 3 months prior to the screening, or have undergone non-laser glaucoma surgery, or have had laser glaucoma surgery within 6 months prior to the screening visit. 4. Ocular secondary scars (such as visible scars from irradiation, chemical burns, Steven-Johnson syndrome, cicatricoid pemphigoid, etc.) that the researcher evaluated may affect the compliance or outcome assessment of the subjects. 5. Those suffering from other autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease). Unless the subject simultaneously meets the following conditions: (1) No steroid drugs, immunomodulatory or immunosuppressive drugs have been used to treat the disease; (2) The researchers believe that their medical condition will not have an impact on the trial results. 6. Those who have undergone organ or bone marrow transplants. 7. Those who have worn contact lenses within 30 days before screening. 8. Within 30 days before the baseline visit (the second visit), oral aspirin or aspirin-containing drugs were taken, or non-steroidal drugs that cause dry eyes (such as anticholinergic drugs, serotonin reuptake inhibitors, beta-blockers, diuretics, etc.) were used (including ophthalmic or systemic use). Unless the subject had been stably using the drug for at least 30 days before the baseline visit and the expected dosage remained unchanged during the trial period. 9.Use the following medications within the specified time before the baseline period (the second visit) : (1) For ocular or systemic use of antihistamines, any ocular medication (including artificial tears) : within 72 hours before the baseline visit (the second visit); (2) Ophthalmic cyclosporine and tacrolimus: within 6 weeks before the baseline visit (the second visit); (3) Ocular or systemic use of steroids or mast cell stabilizers: within 14 days before the baseline visit (the second visit). 10. Those who have had lacrimal punctum plugs/lacrimal duct plugs implanted or have a history of lacrimal punctum cauterization within 12 weeks before screening; Unless the subject has only had a temporary lacrimal punctum plug/lacrimal duct plug implanted, and the researcher assesses that the current time without the lacrimal punctum plug/lacrimal duct plug in the subject's lacrimal duct is >=12 weeks. 11. Within 6 months prior to the screening, yttrium aluminum garnet laser posterior capsulotomy was performed. Have undergone corneal refractive surgery (such as LASIK surgery) or any other ophthalmic surgery within 12 months prior to screening. 12.People who are known to be allergic to fluorescein, allergic to multiple substances, or suffering from severe allergic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in inferior corneal fluorescein staining score (ICSS) in the experimental group and the placebo group; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline in corneal fluorescein staining scores in the experimental and placebo groups;Mean change from baseline in EDS in the experimental and placebo groups;The mean changes from baseline in the visual analogue scale (VAS) of ocular discomfort (burning/stinging, itching, foreign body sensation, eye discomfort, photophobia, pain) were compared between the experimental group and the placebo group;The mean change from baseline in OSDI scores was compared between the experimental group and the placebo group;The mean change in ODS from baseline was compared between the experimental group and the placebo group; | — |
Countries
China
Contacts
Public ContactXinghuai Sun
Eye & ENT Hospital of Fudan University
Outcome results
None listed