Clinical study about the safety and tolerance of a sterile artificial tear solution (PRO-148®) prepared by Laboratorios Sophia, SA de CV, applied on the ocular surface in healthy volunteers

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:

Dry eye syndrome is one of the main cosultation causes and is among the most frequent established diagnoses by the ophthalmologist, althought epidemiologic studies of dry eye disease are rarely published, the few that have been published report that more than 20% of adults aged 45 or more, suffer from dry eye syndrome symptoms. The most widely used treatment for this disease is artificial tear replacement therapy. PRO-148 is an ophthalmic combination that diminishes the loss of topically administered drug in the ocular surface. To evaluate the safety and tolerance of a new ophthalmic solution PRO-148 indicated in treatment of dry eye, tested on the ocular surface in healthy volunteers.

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 one healthy volunteers, were included in the study. They received PRO-148 ophthalmic solution, on both eyes every six hours during 10 days. Clinical evalutation was performed on days 0, 2, 4, 7 and 10. A trained ophthalmologist performed a complete ophthalmologic examination, including: visual acuity, ocular tonometry, corneal surface integrity and fundoscopy. These are the safety parameters taken into account: primary: burning, conjunctival hypereemia, corneal surface integrity, Bengal Rose and fluorescein staining, and tonometry; secondary parameters were: pink eye, tearing, visual acuity, findings at the periocular area, anterior segment, fundoscopic and relation cup/shape.

Results:

A total of 31 patients were evaluated. 19% female and 81% male. The mean age was 33.1 years (18-58 years). Different parameters to assess safety and tolerability, showed few cases with signs and symptoms, most of which were present were reported as mild, there were also variables that did not report a single case. Intra-group results comparison, we compared the data obtained from day 0 (baseline) vs day 10 (final), except for the conjunctival hyperaemia variable, no variable showed statistically significant differences; however, it is noteworthy that the difference reported in conjunctival hyperaemia, is due to a decrease in number of cases with the presence of the variable at baseline with respect to the final. There were no adverse event report.

Conclusions:

PRO-148 has a good tolerability and safety when applied in the ocular surface of healthy volunteers. FINANCIAL DISCLOSURE?: No