Clinical 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 volunteer subjects

Poster Details

First Author: B.Perez MEXICO

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

Abstract Details

Purpose:

The sterile ophthalmic solution PRO-130, is a fixed combination of a lubricant and an eye descongestant. Its use results in reduced patient exposure to ophthalmic solutions and a single application improving symptoms. This will certainly motivate a greater treatment attachment. To evaluate the safety and tolerance of a sterile ophthalmic solution (PRO-130) on the ocular surface of 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 healthy volunteers, received the ophthalmic solution PRO-130 on both eyes every six hours during 10 days. Clinical assesment was done on days 0, 1, 2, 4, 7 and 10; each day a trained ophthalmologist performed a complete questioning regarding symptoms along with a complete eye exam, which included: visual acuity measurement, ocular tonomety and ocular surface and fundoscopic examination. The safety parameters taken into account were dividen into: primary (burning, conjunctival hyperemia, corneal surface integrity, Bengal Rose and fluoresceine staining and tonometry) and secondary (pink eye, tearing, visual acuity, periocular area, anterior segment and fundoscopic findings).

Results:

Thirty male patients between 22 and 44 years old, were enrolled in the study. Findings: Pink eye: day 0 to 7; 0 cases; day 10; right eye 3.3% mild. Burning, day 1; right eye 33.3% mild/ left eye 36.3% mild; day 2; right eye 36.3% mild/ left eye 33.3% mild; day 4; right eye 43.3% mild/ left eye 46.6% mild; day 7; right eye 30% mild/ left eye 30% mild; day 10; right eye 33.3% mild/ left eye 30% mild. Photophobia: day 1; right eye 10% mild/ left eye 10% mild; day 2; right eye 3.3% mild/ left eye 3.3% mild; day 10; right eye 3.3% mild/ left eye 3.3% mild. Tearing: day 7; right eye 3.3% mild. Foreign body sensation: day 0; right eye 6.7% mild/ left eye 3.3% mild; day 4; right eye 3.3% mild; day 7; right eye 6.7% mild/ left eye 3.3% mild. Conjunctival hyperemia: day 2; right eye 3.4% mild. No data registered on changes in visual acuity, chemosis, Bengal Rose and fluorescein staining, intraocular hypertension, corneal surface damage or fundoscopic abnormalities.

Conclusions:

The ophthalmic solution PRO-130 was safe and well tolerated on the ocular surface of healthy volunteers. FINANCIAL DISCLOSURE?: No