Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

March 31, 2012

Study Completion Date

May 31, 2012

Conditions
Dry Eye Syndrome
Interventions
DRUG

PRO-148 Ophthalmic Solution

PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.

DRUG

Active Comparator: SYSTANE ® Ophthalmic Solution

Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.

Trial Locations (1)

44280

"Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara

All Listed Sponsors
lead

Laboratorios Sophia S.A de C.V.

INDUSTRY

NCT01541891 - Efficacy and Safety of PRO-148 Ophthalmic Solution Versus SYSTANE® in the Treatment of Patients With Dry Eye Syndrome | Biotech Hunter | Biotech Hunter