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

Purpose:

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.

Setting:

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

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 lack of keratinization).

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

Conclusions:

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