43
Participants
Start Date
October 1, 2019
Primary Completion Date
May 20, 2020
Study Completion Date
May 20, 2020
PVA Hydrogel
PVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections.
Synvisk-One®
Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections.
Lubelskie Centrum Diagnostyczne, Świdnik
Lead Sponsor
Rottapharm Biotech
INDUSTRY