Clinical Research Directory

Key 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. Key Exclusion Criteria: * Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments. * Evidence of an active ocular infection in either eye. * Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening. * Intraocular inflammation defined as anterior chamber cell or flare \> 1+ by Standardization of Uveitis Nomenclature (SUN) grading in either eye. * Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye. Note: Additional protocol defined Inclusion/Exclusion criteria apply.