The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit 1) and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Inclusion Criteria:

• Willing and able to attend all study visits.
• Use of BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day).
• At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear.
• Use provided artificial tear at least once a week during run-in phase.
• Willing to take study treatment as directed for the entire study and able to complete the study diaries as required.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Use of artificial tears, as specified in the protocol.
• Use of topical ocular medications, as specified in the protocol.
• Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.
• Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations.
• Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol.
• Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit.
• Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study.
• Contact lens use within 2 weeks prior to Screening Visit, and unwilling to avoid contact lens use during the course of the study.
• Other protocol-specified exclusion criteria may apply.

This analysis population includes all randomized subjects who received at least 1 dose of the randomized investigational product (Intent-to-Treat Analysis Set).

Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 6 weeks). AEs are reported as pre-treatment and treatment-emergent

An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.