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 |
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.
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.
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.
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