First Author: Y.Contreras MEXICO
Co Author(s):
Purpose:
To evaluate the clinical and histopathological safety and toxicity of an ophthalmic solution PRO-130 (oximetazoline + carboxy metilcelulose) when applied to the ocular surface of New Zealand rabbits.
Setting:
: Laboratorios Sophia, SA de CV Paseo del Norte No. 5255 Guadalajara Technology Park Carretera Guadalajara-Nogales Km. 13.5 Zip code 45010 Jalisco, Mexico +52 (33) 30014283
Methods:
Sixteen rabbits were numbered and divided into two groups. Group one received the ophthalmic solution PRO-130 in their left eye and placebo in the right one. The second group, received placebo en the left eye and PRO-130 in their right eye. Instillation was scheduled every two hours between 7 to 19 hrs, during 15 days. Clinical assessment was accomplished on days 0, 1, 2, 4, 7, 10 and 15. Safety parameters taken into account were: conjunctival hyperemia, chemosis, corneal surface integrity, conjunctival secretion, Bengal Rose and fluorescein staining. At days 0 and 15, fundoscopy was achieved trough pharmacologic mydriasis. During the 16th day, all rabbits were sacrificed an enucleated. Histopathology study was executed, and the following findings were recorded: cornea, changes in epithelial thickness, basal membrane integrity, cellular changes, conjunctiva (presence of goblet cells, apoptosis or diskeratinization).
Results:
Thirty-two eyes were assessed. Sixteen eyes were treated with PRO-130, and 16 eyes received placebo. None of the clinical manifestations was associated with the ophthalmic solution PRO-130. No cytological toxicity changes were found in the histopathological study.
Conclusions:
The ophthalmic solution PRO-130 is clinical and histopathological safe when applied to the ocular surface of New Zealand rabbits.
Financial Disclosure:
No
