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 qualifybased 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 correctionduring the study period (if applicable)

• If using any form of topical ophthalmic cyclosporine (i.e., RESTASIS®) orlifitegrast 5% ophthalmic solution (Xiidra®), participants must be using the dropsfor ≥90 days prior to the Screening (Day -7) visit and plan to continue withoutchange for the duration of the study

• A female participant is eligible to participate if she is not pregnant (i.e., has anegative in-office urine pregnancy test at Screening [Day -7] and does not verballyreport pregnancy at the Day 1 [Baseline] visit; is not breastfeeding, and at least 1of the following conditions applies:

1. A woman not of childbearing potential (WOCBP) OR

2. A WOCBP who agrees to follow the contraceptive guidance for the duration of thestudy

Exclusion Criteria:

• Have uncontrolled severe systemic disease that, in the assessment of theinvestigator, would put safety of the participant at risk through participation, orwhich would prevent or confound protocol-specified assessments (eg, hypertension anddiabetes, 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, whichin 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) ocularinflammation

• Active ocular allergy

• History of recurrent herpes keratitis or active disease within 6 months priorto the Screening (Day -7) visit

• Corneal disorder or abnormality that affects corneal sensitivity or normalspreading of the tear film (except superficial punctate keratitis)

• Severe blepharitis or obvious inflammation of the lid margin, which in thejudgment of the investigator, may interfere with the interpretation of thestudy results

• Keratoconjunctivitis sicca secondary to the destruction of conjunctival gobletcells, such as occurs with vitamin A deficiency or scarring such as that withcicatricial pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, orirradiation

• Substantial non-KCS keratitis with overlying corneal stain or other significantcorneal findings not directly related to DED; in addition, participants withDED signs/symptoms (eg, filamentary keratitis) of a severity where topicalmonotherapy 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) orvision is <90 days prior to the Screening (Day -7) visit or a change in dosage isanticipated during the study.

Systemic medications, which may affect DED or vision, include but are not limited to the following: flax seed oil, fish oil, omega-3 supplements, cyclosporine, antihistamines, cholinergic agents, anticholinergics, antimuscarinics, beta blocking agents, tricyclic antidepressants, phenothiazines, estrogen, progesterone, and other estrogen derivatives

• Have occlusion of the lacrimal puncta for either eye, with punctal plugs orcauterization < 6 months prior to the Screening (Day -7) visit or anticipated use ofsuch procedures during the study

• Use of lid-heating therapy (i.e., LipiFlow®, iLUX®, etc.), Meibomian gland probing,or therapeutic Meibomian gland expression in either eye < 6 months prior to theScreening visit (Day -7) or anticipated use during the study

• Have history of ocular/ophthalmic surgery or trauma, which could affect cornealsensitivity and/or tear distribution (eg, cataract surgery, laser-assisted in situkeratomileusis [LASIK], photorefractive keratectomy, or any surgery involving alimbal or corneal incision) within 12 months prior to the Screening (Day -7) visit

• Are currently using topical ocular medication (OTC, herbal or prescription) orTrueTear® (intranasal neurostimulator), or have used topical ocular medication (OTC,herbal or prescription) or TrueTear within 1 month of the Screening (Day -7) visitor plan use of such treatments during the study. Exception: participants who areusing the following can be considered:

• Marketed artificial tear product for the management of DED, which must bediscontinued at the Screening (Day -7) visit

• Monotherapy for glaucoma or ocular hypertension (OHT) using a prostaglandinanalog, beta blocker, alpha-2 agonist, or carbonic anhydrase inhibitor; anytopical intraocular pressure (IOP)-lowering medications must have a start dateof ≥ 90 days prior to the Screening (Day -7) visit and dosage is not expectedto change during the study

• Cyclosporine topical ophthalmic preparation (eg, RESTASIS or other ophthalmicform) or lifitegrast 5% ophthalmic solution (Xiidra), with a start date of ≥ 90days prior to the Screening (Day -7) visit and dosage is not expected to changeduring the study NOTE: Participants currently being treated with BOTH anIOP-lowering medication and topical ocular cyclosporine or lifitegrast cannotbe enrolled.

• Are currently enrolled in an investigational drug or device study or participationin such a study within 30 days of entry into this study at the Screening (Day -7)visit

• Report an average daily artificial tear use of >6 times per day within 6 months ofthe Screening (Day -7) visit

• Females who are pregnant, nursing, or planning a pregnancy during the study orfemales who are of childbearing potential and not using a reliable method ofcontraception

• Have history of allergies or sensitivity to the study interventions or itscomponents (including all REFRESH and Systane product lines) or diagnostics (eg,topical ocular anesthetic, sodium fluorescein, or lissamine green).