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

Completed · Not applicable

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT03492541

Run by

Alcon Research

People needed

134

Starts

2018-07-18

Expected to finish

2019-05-14

Last updated by the study team

2019-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigative Site — Kansas City, Missouri, United States
• Investigative Site — Kansas City, Missouri, United States
• Investigative Site — Norfolk, Virginia, United States
• Investigative Site — Valladolid, Castille and León, Spain
• Investigative Site — London, United Kingdom

Full record on ClinicalTrials.gov

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