An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

Inclusion Criteria

• •A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye).
• •The global score of the SANDE questionnaire ≥ 30
• •DED in at least one eye which is characterized by the following clinical features:
• •1. Schirmer I test without anesthesia \< 10 mm/5 minutes, and
• •2. Total CFS grade ≥ 4 assessed by the NEI grading system, and
• •3. Fluorescein tear film break-up time (TFBUT) \< 10 seconds.
• •Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \[LogMAR\]) in each eye at the time of study enrollment.
• •Only participants who satisfy all informed consent requirements will be included in the study.