NCT01541891

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

Fase II Comparative Study of the Efficacy and Safety of PRO-148 Ophthalmic Solution vs Systane in the Treatment of Mild-to-moderate Eye Syndrome.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Detailed description

A phase 2, randomized, double masked clinical, parallel-group clinical trial to evaluate the efficacy and safety of PRO-148 ophthalmic solution compared with SYSTANE ® ophthalmic solution for the treatment of signs and symptoms of mild-to-moderate dry eye syndrome.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-03-01
• Completion: 2012-05-01
• First posted: 2012-03-01
• Last updated: 2018-10-30
• Results posted: 2018-10-30

Locations

1 site across 1 country: Mexico