Study of Efficacy and Tolerability of SYSTANE Complete in Patients With Dry Eye Disease

Evaluation of the Clinical Efficacy and Tolerability of SYSTANE Complete in Adult Patients With Dry Eye Disease Following Topical Ocular Use for 4 Weeks: A Multicenter Trial

The purpose of this study is to evaluate the clinical effectiveness and tolerability of SYSTANE® Complete in adult patients with dry eye disease. Fluorescein-stained tear film break-up time (TFBUT) will be evaluated as the primary objective.

Patients will attend 4 scheduled visits: Screening Visit (Day -7 to Day 0), Visit 1/Baseline Visit (Day 1), Visit 2 (Day 14) and Visit 3 (Day 28).

Inclusion Criteria:

• Must have TFBUT of ≤ 5 seconds in at least one eye at Screening visit.
• Must have best corrected visual acuity (BCVA) of ≥ 20/80 (or ≥ 55 letters score or ≥ 0.6 early treatment diabetic retinopathy study (ETDRS) log of the minimum angle of resolution (LogMAR) value) in both eyes at the Screening visit.
• Must be willing to discontinue use of all artificial tear supplements and use only the study product as directed for the entire study duration.

Exclusion Criteria:

• History of hypersensitivity to the study drug or any of its excipients or to drugs of similar chemical classes.
• Use of any topical ocular medication preserved with benzalkonium chloride or other products known to be toxic to the tear film lipid layer within 1 month prior to the Screening visit.

Other protocol-specified inclusion and exclusion criteria may apply.