Clinical study about the safety and tolerance of an anti-allergic ophthalmic solution (PRO-118®) prepared by Laboratorios Sophia, SA de CV, applied to the ocular surface in healthy volunteer subjects

Poster Details

First Author: C.Ramos-Castell MEXICO

Co Author(s):    A. Contreras Rubio   L. Baiza Dur   B. P   G. Flores Te     

Abstract Details

Purpose:

Allergic conjunctivits management, should be focused on eliminating or avoiding the allergen, however, this is not possible very often. Several drugs have been used to treat allergic conjunctivitis, like: cold compresses, ocular lubricants, antihistamines and decongestants combined with mast cell stabilizers, and try to make an optimal environment for the patient. The newer generation of antihistamines has a strong affinity to H1 receptors, and has even demonstrated that it doesn“t cause dry eye or xerostomy. PRO-118 is a novel, potent and highly selective H1 anthisitamine, non-sedating, with quick action. To evaluate the safety and tolerance of a new sterile ophthalmic solution PRO-118® on the ocular surface in healthy volunteer patients.

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:

Thirty healthy patients, will have an instillation in both eyes, four times a day (every six hours) for ten days. They were assessed on days 0, 1, 2, 4, 7 and 10, each day the ophthalmologist will perform a complete ophthalmologic examination, including visual acuity, ocular tonometry, ocular surface review and fundoscopy. These are the safety parameters taken into account: primary: burning, conjunctival hyperaemia, corneal surface integrity, Bengal Rose and fluorescein staining, and tonometry; secondary parameters: pink eye, tearing, visual acuity, findings in the periocular area, anterior segment, fundoscopic and cup/disc relation findings.

Results:

Intra-group evaluation results, in which we compared the data obtained during day 0 (baseline) vs day 10 (final), the variables that showed statistically significant differences (p<0.05) were: pink eye, tearing, conjunctival hyperaemia, intraocular pressure and cup/disc relation, the remaining variables showed no statistically significant differences (p>0.05), ie no change on baseline visit findings compared with the final visit (day 10).

Conclusions:

In the different safety and tolerability variables there were few cases with signs and symptoms presence, and most were referred as mild intensity. In statistically significant different variables, were due to the decrease in cases or values in the evaluated parameters, founded at initial visit (day 0) compared with regard to the final visit (day 10). Therefore, we can conclude that PRO-118, has a good tolerance and safety in healthy subjects. FINANCIAL DISCLOSURE?: No