CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 137 enrolled
Drug / intervention
loteprednol etabonate and tobramycin +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00705159
NCT00705159Phase 4Completed
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Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis

Bausch & Lomb Incorporated·interventional·Posted Jun 25, 2008·Updated Mar 24, 2015

In Brief

A Phase 4 clinical trial evaluating loteprednol etabonate and tobramycin, loteprednol etabonate, and 2 other interventions for Conjunctivitis. Completed, enrolled 137 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConjunctivitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 25, 2008
Enrollment StartJun 1, 2008
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago

Interventions

loteprednol etabonate and tobramycindrug

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

loteprednol etabonatedrug

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

Tobramycindrug

Topical ocular administration of Tobramycin QID for 14 days.

Vehicle of Zyletdrug

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