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Paloma Marquez, Leopoldo Martin Baiza-Duran, Yussett Contreras, Oscar Olvera Montaño, Juan D Quintana-Hau, Juan Carlos Rivera; Preclinical safety profile of a preservative free gellan gum/ sodium hyaluronate artificial tear combination. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4480.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the clinical and histopathological safety of a gellan gum/sodium hyaluronate based new artificial tear, when applied to rabbit eyes.
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.
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.
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.
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