166
Participants
Start Date
December 13, 2017
Primary Completion Date
September 14, 2018
Study Completion Date
October 31, 2018
PRO-155
"PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014~Sodium hyaluronate 0.4% \[Lagricel ofteno®\] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
Placebo
"The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL~Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
catarata y glaucoma de occidente S.A de C.V., Guadalajara
Novam y Vita, Guadalajara
Consultorio PRivado Miguel Angel Villanueva, Mexico City
Laboratorios Sophia S.A de C.V.
INDUSTRY