Efficacy of 0.18% hypotonic sodium hyaluronate ophthalmic solution in the
treatment of signs and symptoms of dry eye disease.
Author(s): Baeyens V, Bron A, Baudouin C; Vismed/Hylovis Study Group.
Collaborators: Allali J, Arnoux Y, Arrata M, Baudouin C, Benchaboune M, Besnainou
N, Bourcier T, Bron A, Chiambaretta F, Cochener B, Colin J, Colliot JP,
Creuzot-Garcher C, Delbosc B, Delfour-Malecaze M, Dussueil O, Febbraro JL,
Galtier E, Gilg AN, Girard B, Jackson A, Kumar V, Labetoulle M, Laroche L, Liu C,
Malecaze F, Mathiot-Michel E, Moore J, Murphy P, Partouche P, Partouche-Ferber J,
Pisella PJ, Platkiewicz S, Protat P, Redor JY, Robert PY, Roncin S, Sabadel A, de
Saint-Etienne F, Shah S, Sultan G, Vabres B, Veschambre MC, Vigot P, Wollfhson J.
Affiliation(s): TRB Chemedica International SA, 12, rue Michel-Servet, P.O. Box 352 1211, Geneva
12, Switzerland.
Publication date & source: 2012, J Fr Ophtalmol. , 35(6):412-9
BACKGROUND/AIMS: To compare the safety and efficacy of hypotonic 0.18% sodium
hyaluronate solution (0.18% SH) versus saline and versus 0.3% carbomer for the
treatment of signs and symptoms of moderate dry eye syndrome.
METHODS: A total of 304 patients were randomized (1:1:1) in this parallel-group,
multi-center, phase III trial. They were instructed to instill one drop of the
allocated product in each eye two to four times per day over 84 days. The primary
efficacy criterion was the change from baseline at Day 28 in symptom frequency
score. The superiority of 0.18% SH (Vismed(®)) over saline and its
non-inferiority versus carbomer were statistically tested.
RESULTS: At Day 28, there was a statistically significant superiority of 0.18% SH
over saline in change from baseline for subjective symptom frequency score
(P=0.0376, primary endpoint) and objective fluorescein staining score (P=0.0074,
secondary endpoint). 0.18% SH had an excellent safety profile over 84 days. A
strong trend was observed in favour of 0.18% SH to cause less blurred vision than
carbomer throughout the trial (P=0.0798 at Day 28).
CONCLUSION: 0.18% SH caused a statistically significant improvement in both a
subjective endpoint (symptom frequency score) and an objective endpoint
(fluorescein staining score). 0.18% SH was well tolerated and resulted in low
incidence of adverse events.
|