CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 108 enrolled
Drug / intervention
loteprednol etabonate/tobramycin opthalmic suspension +1 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/NCT00420628
NCT00420628Phase 4Completed
CompareCT.gov

A Safety and Efficacy Study of Zylet® (Loteprednol Etabonate 0.5% and Tobramycin 0.3% Ophthalmic Suspension) Compared to Vehicle in the Management of Lid Inflammation (Chalazion/Hordeolum) in Pediatric Subjects

Bausch & Lomb Incorporated·interventional·Posted Jan 11, 2007·Updated Oct 7, 2011

In Brief

A Phase 4 clinical trial evaluating loteprednol etabonate/tobramycin opthalmic suspension and vehicle for Chalazion and Hordeolum. Completed, enrolled 108 participants across 1 site.

Detailed Summary

A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChalazion, Hordeolum
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2007
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.5 years ago

Interventions

loteprednol etabonate/tobramycin opthalmic suspensiondrug

Topical ophthalmic drug: 0.5% loteprednol etabonate with 0.3% tobramycin 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.

vehicledrug

topical ophthalmic vehicle was applied 4 times a day (QID) days 1-7, 2 times a day (BID) days 8-14. Warm compresses were applied to affected eyes 2 times a day prior to application of study medication.