Abstract
Purpose:
To evaluate clinical and histopathological safety and toxicity of preservative free azithromycin /dexamethasone ophthalmic solution (AZi/DX) in rabbit eyes.
Methods:
Thirty healthy New Zealand White rabbits were included in this study. Doses were given 4 times a day for 30 days. Slit lamp examination, fluorescein and lissamine green staining were performed on days 2, 5, 10, 15, 20, 25 and 30; additionally intraocular pressure (IOP) was measured on days 15, 20, 25 and 30. On day 31 rabbits were euthanized and eyes enucleated for histopathological assessment. Conjunctival hyperemia, chemosis, corneal staining, conjunctival discharge and IOP were assessed as clinical toxicity and safety criteria.
Results:
Compared with baseline, hyperemia was the only variable that showed statistically significant changes during visits, nonetheless, was rated as minimal or mild. No increase in IOP was found. In the histopathological report there were no signs of cellular toxicity.
Conclusions:
Conjunctival hyperemia is a nonspecific sign of toxicity, especially when considering it is unrelated to any other finding, including histopathological evaluations. Thus we can conclude AZi/DX it is safe when applied in rabbit eyes.