This study is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of Lifitegrast Ophthalmic Solution.
Voluntary participation and signing of the informed consent form, willingness to comply with the treatment regimen prescribed by the trial protocol, and willingness to attend follow-up visits on time.
Age ≥18 years, regardless of gender.
Best corrected visual acuity ≥4.3 in both eyes (OU) at the screening visit (V1 visit).
History of dry eye disease in both eyes prior to the screening visit (V1 visit) (with at least one subjective symptom such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, eye redness, or fluctuating vision).
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.
Presence of eyelid margin structural abnormalities (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann's nodular corneal degeneration, conjunctival goblet cell damage (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, or other ocular diseases that, in the investigator's opinion, may increase the subject's risk or affect the trial results.
Ocular secondary scarring (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.) that, in the investigator's opinion, may affect subject compliance or outcome assessment.
Subjects with secondary Sjögren's syndrome or other autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.), unless the subject meets the following conditions: a. Not using corticosteroids, immunomodulatory, or immunosuppressive drugs for the condition; b. The investigator considers that the medical condition will not affect the trial results.
Parallel
Drug placebo
DrugInstill one drop of the eye solution in each eye, twice a day (morning and evening, approximately 12 hours apart), for a treatment period of 12 weeks.
Inferior Corneal Fluorescein Staining Score
After 84 days of treatment, the mean change from baseline in the Inferior Corneal Fluorescein Staining Score (ICSS，0-4) in the treatment group was compared with that in the placebo group. A higher corneal fluorescein staining score indicates a worse condition
Eye Dryness Score
After 84 days of treatment, the mean change from baseline in the Eye Dryness Score (EDS, 0-100 \[VAS, Visual Analog Scale\]) in the treatment group was compared with that in the placebo group.A higher Eye Dryness Score indicates a worse condition.
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Lunan Better Pharmaceutical Co., LTD.
Lead sponsor
Beijing Tongren Hospital
Collaborator
