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



Status:Recruiting
Conditions:Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/27/2019
Start Date:July 18, 2018
End Date:May 9, 2019
Contact:Novartis Pharmaceuticals
Email:alcon.medinfo@alcon.com
Phone:1-888-669-6682

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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).

This study is sponsored by Alcon, A Novartis Company.

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.
We found this trial at
3
sites
Norfolk, Virginia 23507
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Kansas City, Missouri 64111
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Kansas City, MO
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London,
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