Preclinical safety and acute toxicity of a sterile artificial tear solution (PRO-148) prepared by Laboratorios Sophia, SA de CV, applied to the ocular surface in healthy New Zealand rabbits

Poster Details

First Author: Y.Contreras MEXICO

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

Abstract Details

Purpose:

Actually, there are many alternatives for dry eye syndrome treatment (besides ocular lubricants) ranging from topic immunomodulator drugs to punctal occlusion. Despite all treatment alternatives, ocular lubricants are still the main treatment to this ailment. One of the major problems encountered in ophthalmology, is topical medications bioavailability, and its extremely fast elimination. Scientific investigation emphasizes it“s research on trying to increase drug retention through drug combinations, on the ocular surface, generating increased bioavailability to their action site. PRO-148 is an ophthalmic combination that decreases the loss of topically administered drug due to the volume that supports the ocular surface. To evaluate the clinical and histopathological safety and acute toxicity of a new artificial tear solution PRO-148 indicated in treatment of dry eye, tested on the ocular surface in healthy 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 four groups. Group one, received the ophthalmic solution PRO-148 in their right eye and placebo at the left eye; group two received PRO-148 in their left eye and placebo in the right eye. Rabbit 15 was at the third group, and it received PRO-148 ophthalmic solution in both eyes; group four was rabbit 16, which received placebo in both eyes. The instillation was scheduled every two hours between 7 and 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. On days 0 and 15, fundoscopy was performed under pharmacological mydriasis. At day 16, all rabbits where sacrificed and enucleated. A blind histopathological study was executed and the tissues were examined in order to determine: cornea (changes in the epithelial thickness, basal membrane integrity, cellular changes), conjunctiva (presence of goblet cells, apoptosis, diskeratinization).

Results:

Thirty-two eyes were assessed, 16 were treated with PRO-148 solution and 16 with placebo. The safety parameters evaluated were equally present with PRO-148 ophthalmic solution and with placebo. No cytological toxicity changes were found

Conclusions:

The ophthalmic solution PRO-148 is clinical and histopathological safe when applied to the ocular surface of New Zealand rabbits. FINANCIAL DISCLOSURE?: No