Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease

Inclusion Criteria

• At the Screening (Day -7) and Baseline (Day 1) visits, at least 1 eye must qualify based on corneal and conjunctival staining scores
• Have used an artificial tear product for DED within 6 months of the Screening (Day -7) visit
• Have ability/agreement to continue to wear existing current spectacle correction during the study period (if applicable)
• If using any form of topical ophthalmic cyclosporine (i.e., RESTASIS®) or lifitegrast 5% ophthalmic solution (Xiidra®), participants must be using the drops for ≥90 days prior to the Screening (Day -7) visit and plan to continue without change for the duration of the study
• A female participant is eligible to participate if she is not pregnant (i.e., has a negative in-office urine pregnancy test at Screening [Day -7] and does not verbally report pregnancy at the Day 1 [Baseline] visit; is not breastfeeding, and at least 1 of the following conditions applies:
• A woman not of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance for the duration of the study

Exclusion Criteria

• Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (eg, hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.)
• Participant has worn contact lenses in the last 90 days prior to the Screening (Day -7) visit and/or participant anticipates contact lens wear during the study
• Have any scheduled or planned systemic surgery or procedure during the study, which in the investigator's opinion, may impact the participant's study participation
• Presence of 1 or more of the following ocular conditions:
• Active ocular infection or non-keratoconjunctivitis sicca (KCS) ocular inflammation
• Active ocular allergy
• History of recurrent herpes keratitis or active disease within 6 months prior to the Screening (Day -7) visit
• Corneal disorder or abnormality that affects corneal sensitivity or normal spreading of the tear film (except superficial punctate keratitis)
• Severe blepharitis or obvious inflammation of the lid margin, which in the judgment of the investigator, may interfere with the interpretation of the study results
• Keratoconjunctivitis sicca secondary to the destruction of conjunctival goblet cells, such as occurs with vitamin A deficiency or scarring such as that with cicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation
• Substantial non-KCS keratitis with overlying corneal stain or other significant corneal findings not directly related to DED; in addition, participants with DED signs/symptoms (eg, filamentary keratitis) of a severity where topical monotherapy with an artificial tear would be inappropriate
• The start date of any systemic medication (including over-the-counter [OTC], herbal, prescription, or nutritional supplements) which may affect Dry Eye Disease (DED) or vision is 6 times per day within 6 months of the Screening (Day -7) visit
• Females who are pregnant, nursing, or planning a pregnancy during the study or females who are of childbearing potential and not using a reliable method of contraception
• Have history of allergies or sensitivity to the study interventions or its components (including all REFRESH and Systane product lines) or diagnostics (eg, topical ocular anesthetic, sodium fluorescein, or lissamine green).