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Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

NCT00705159 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2015-03-24

Study results available
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Summary

The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.

Conditions

Interventions

DRUG

loteprednol etabonate and tobramycin

Topical ocular administration of loteprednol etabonate and tobramycin 4 times per day (QID) for 14 days.

DRUG

loteprednol etabonate

Topical ocular administration of Lotemax (loteprednol etabonate) QID for 14 days.

DRUG

Tobramycin

Topical ocular administration of Tobramycin QID for 14 days.

DRUG

Vehicle of Zylet

Topical ocular administration of the vehicle of Zylet QID for 14 days.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Week
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00705159 on ClinicalTrials.gov