Dry eye
Conditions
Interventions
Trial group:Lifitigrast eyedrop
Control group:Lifitigrast placobo eyedrop
Sponsors
Xiamen eye center of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or over, regardless of gender; 2.Clear understanding of and voluntary participation in the study, with written informed consent signed by the participant, and willingness and ability to comply with all trial assessments and visits as instructed; 3.Male subjects and female subjects of childbearing potential must agree to use medically accepted contraception during the trial and for 3 months (90 days) after the end of the trial; female subjects who are not postmenopausal or have not been postmenopausal for less than two years (from the last menstrual period to signing the ICF for this project) must have negative pregnancy tests at visits 0 and 1; 4.A history of bilateral dry eye disease before the screening visit (visit 0) (with at least one subjective symptom such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, fluctuation in vision, etc.) for at least 180 days; 5.Recent use of artificial tears to relieve dry eye-related symptoms (within the past 30 days before visit 0), with discontinuation of artificial tears for at least 72 hours before visit 0; 6.At visit 0, the Chinese version of the Dry Eye Questionnaire (DEQ) score >= 7 or the Ocular Surface Disease Index (OSDI score) >= 13; 7.Dryness score (EDS, VAS scale) >= 40 points at visits 0 and 1 (0-100 points); 8.Best-corrected visual acuity of both eyes >= 4.3 (International Standard Logarithmic Visual Acuity Chart, 5-meter reading, 5-point recording method) at visit 0; 9.Corneal fluorescein staining score of at least one area of at least one eye >= 2 points at visits 0 and 1 (0-4 points); 10.Conjunctival redness score of at least one eye >= 1 point (allowing for 0.5-point increments) at visits 0 and 1 (0-4 points); 11.At the screening visit and baseline visit (visits 0 and 1), at least one eye, and the same eye, meets the following criteria: 1) Inferior corneal staining score (ICSS) >= 0.5 points (allowing for 0.5-point increments); 2) Unanesthetized Schirmer's Test I (STT) result >= 1 and <= 10 mm/5 min.
Exclusion criteria
Exclusion criteria: Medical History: 1.History of ocular or periocular malignant tumors; 2.Dry eye secondary to scars (e.g., radiation, chemical burns, Stevens-Johnson syndrome, scarred pemphigoid) or cup-shaped cell destruction of the conjunctiva (e.g., vitamin A deficiency); 3.Ocular allergy in acute phase or the potential occurrence of ocular allergy during the trial; 4.Presence of eye or systemic infections (bacterial, viral, or fungal) at visits 0 and 1, including fever, herpetic keratitis, or currently undergoing antibiotic treatment; 5.History of any of the following: immunodeficiency, HIV infection, hepatitis B, hepatitis C, acute active hepatitis A (anti-HAV IgM positive), organ or bone marrow transplantation; 6.Any major chronic illness that the investigator believes may interfere with study parameters, including but not limited to: severe cardiopulmonary disease, poorly controlled hypertension and/or poorly controlled diabetes; 7.Blood donation or significant blood loss (over 400ml) within 56 days before visit 0. Physical Examination or Laboratory Abnormalities: 8. Active rosacea-related ocular lesions, periocular acne, or chalazion; 9.Anatomical abnormalities of the eyelids (e.g., incomplete eyelid closure, entropion or ectropion) or blink abnormalities; 10.Clinical significant abnormalities found during the slit lamp and/or fundus examination at visit 0 that require medication treatment and are deemed by the investigator to potentially interfere with trial results. Past Medication or Treatment: 11. Underwent intraocular or ocular laser surgery, YAG laser capsulotomy, or any surgery affecting the meibomian glands, LipiFlow meibomian gland thermal pulsation treatment, or intense pulsed light (IPL) therapy within 180 days before visit 0 or planned during the trial; 12.Received punctal occlusion or had punctal plugs removed (resorbable plugs within 180 days), or planned punctal occlusion or removal of plugs during the trial, or the time for resorbable plugs to dissolve is within the trial period, within 90 days before visit 0; 13.Received systemic immunomodulatory agents, oral streptomycin or tetracycline within 90 days before visit 0 or planned to irregularly use the aforementioned drugs during the trial; 14.Used topical antiglaucoma eye drops within 90 days before visit 0, or received any time before the trial a glaucoma implant (e.g., Durysta); 15.Used immunomodulators (such as cyclosporine A eye drops, tacrolimus eye drops, etc.) within 42 days before visit 0; 16.Used any known medication causing dryness of the eyes (e.g., diuretics, antidepressants, decongestants, antispasmodics, antihistamines, anesthetics, etc.) within 30 days before visit 0, or planned to irregularly use the aforementioned drugs during the trial; 17.Received treatment for active blepharitis or blepharoconjunctivitis (such as lid scrubs, lid massage, compresses, warm compresses, systemic antibiotics, and other oral medications for treating eye diseases) within 30 days before visit 0, or planned to irregularly undergo treatment during the trial; 18.Used steroids or mast cell stabilizers (including ocular) within 14 days before visit 0; 19.Worn contact lenses within 7 days before visit 0, or planned to continue wearing during the trial; 20.Known allergy to Xiidra or its excipients, investigational drugs or their excipients, fluorescein, or other substances involved in the examination. Other: 21. Pregnant, breastfeeding, or planning pregnancy for female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analog Scale;Corneal fluorescein staining score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ocular Surface disease index;Chinese Dry Eye Questionnare;Ocular Discomfort Scale;conjunctival redness score;Schirmer test; | — |
Countries
China
Contacts
Public ContactZuguo Liu
Xiamen Eye Center of Xiamen University
Outcome results
None listed