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Preclinical safety profile of a preservative-free gellan gum/ sodium hyaluronate artificial tear combination
Poster Details
First Author: O.Olvera MEXICO
Co Author(s):
Abstract Details
Purpose:
To evaluate the clinical and histopathological safety of a gellan gum/sodium hyaluronate based new artificial tear, when applied to rabbit eyes.
Setting:
Medical Research Department Laboratorios Sophia, Zapopan, Jalisco, Mexico
Methods:
Thirty healthy male New Zealand White rabbits (60 eyes) were included in this study. The preservative free gellan gum 0.35%/ sodium hyaluronate 0.5% ophthalmic solution was applied 4 times a day for 30 days in both eyes.
Slit lamp examination (conjunctival hyperemia, chemosis and conjunctival discharge evaluation) and corneal staining
were performed on days 2, 5, 10, 15, 20, 25 and 30 of the study. On day 31 rabbits were sacrificed and enucleated for
hysthopathological assessment
Results:
Conjunctival hyperemia, graded minimal or mild, was encountered through all the evaluations, being
statistically significant compared with baseline (p<0.05), reaching its highest peak on day 20, with 36.7% (n= 22). On
day 2, conjunctival discharge was present in 8.3% (n=5), also reaching a statistically significant difference compared
with baseline. No hystopathological changes were reported
Conclusions:
The security parameters evaluated in this study showed that the combination of gellan gum/sodium
hyaluronate is clinically and histologically safe and non-toxic to the ocular surface. Further studies are warranted to
assess the impact of this formulation on tear film stability and corneal protection.
Financial Disclosure:
NONE