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

NCT01541891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-30

Study results available
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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.

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.

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • José F Alaniz-De La O, MD · Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

  • Laura R Saucedo-Rodíguez, MD · Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

  • Leopoldo M Baiza-Durán, MD · Clinical Research Department. Laboratorios Sophia SA de CV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-03-31
Completion
2012-05-31

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01541891 on ClinicalTrials.gov