To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment. To evaluate the performance and safety of T2769 versus Vismed® Multi.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
251
T2769: sodium hyaluronate, Trehalose, Naaga in a 12.5 mL ABAK® multi-dose bottle.
Hyaluronic acid
Gabriel-Montpied University Hospital
Clermont-Ferrand, France
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : Minimum 0- Maximum 15)
Change from baseline (Day 1) in the worse eye at Day 36 in Global Ocular staining (decrease of oxford score = better outcome)
Time frame: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
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