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Preclinical study about the safety and tolerance of a two drug combination ophthalmic solution of vasoconstrictor and lubricant (PRO-130) prepared by Laboratorios Sophia, SA de CV, applied to the ocular surface in healthy New Zealand rabbits

Poster Details

First Author: B.Perez MEXICO

Co Author(s):    A. Contreras Rubio   L. Baiza Dur   C. Ramos Castell   G. Flores Te   L. Urquides Espinoza   A. Rodr

Abstract Details


One of the most common clinical findings in ophthalmology, is the conjunctival hyperaemia (pink eye). This clinical sign goes with a large number of ocular ailments, ranging from environmental conjunctivitis to infectious eye diseases. Decongestants (vasoconstrictors) administered topically in combination with a polymer, with viscous-adhesive properties, can stabilize the tear film; therefore they are a good option to treat this common ailment. PRO-130 solution is a combination of both drugs to enhance their activity. To evaluate the clinical and histopathological safety and toxicity of an ophthalmic solution PRO-130 when applied to the ocular surface of New Zealand rabbits.


Laboratorios Sophia, SA de CV Paseo del Norte No. 5255 Guadalajara Technology Park Carretera Guadalajara-Nogales Km. 13.5 Zip code 45010 Zapopan, Jalisco, Mexico +52 (33) 30014283


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 lack of keratinization).


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 PRO-130 ophthalmic solution. No cytological toxicity changes were found in the histopathological study.


The ophthalmic solution PRO-130 is clinically and histopathologically safe when applied to the ocular surface of New Zealand rabbits. FINANCIAL DISCLOSURE?: No

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