The purpose of this study is to evaluate the efficacy and safety of Systane® Gel Drops in dry eye subjects following 90 days of QID (4 times/day) dosing.

Inclusion Criteria:

• Must give informed consent, and be willing and able to attend all study visits.
• Best-corrected visual acuity (BCVA) of ≥ 55 letters in each eye as measured by ETDRS (letters read method).
• Dry eye in both eyes diagnosed by an ophthalmologist.
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant, test positive on a pregnancy test, or breast-feeding.
• Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of test article or safe participation in the study.
• Any contraindications or hypersensitivities to the study medications or their components.
• Ocular surgery (of any type, including PRK, LASIK, Epilasik, etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
• Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening.
• Chronic medications (over the counter, prescription, or vitamins) that have not been on a stable dose for at least 30 days prior to Screening.
• Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study.
• Participation in any other clinical trial within 30 days prior to Screening.
• Other protocol-specified exclusion criteria may apply.

This analysis population includes all subjects who were exposed to investigational product (Safety Analysis Set).

Adverse Events (AEs) were collected from the time of informed consent for the duration of a subject's participation in the study (up to 90 days). AEs are reported as pre-treatment and treatment-emergent.

An AE was defined as any untoward medical occurrence in a subject who was administered an IP regardless of whether or not the event had a causal relationship with the IP. AEs were obtained through elicited and spontaneous comments from subjects and through observations by the Investigator.