Completed

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

What is being tested

loteprednol etabonate/tobramycin opthalmic suspension

+ vehicle

Drug

Who is being recruted

Bacterial Infections and Mycoses+8

+ Bacterial Infections

+ Cysts

Until 6 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 4

Interventional

Study Start: November 2006

See protocol details

Summary

Principal SponsorBausch & Lomb Incorporated

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2006

Actual date on which the first participant was enrolled.

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)

Official TitleA 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

NCT00420628

Principal SponsorBausch & Lomb Incorporated

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 6 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBacterial InfectionsCystsEye DiseasesEyelid DiseasesHordeolumInfectionsNeoplasmsEye InfectionsEye Infections, BacterialChalazion

Criteria

4 inclusion criteria required to participate

Child, 0 to 6 years of age, any sex and race

Subject must have a clinical diagnosis of lid inflammation (e.g. Chalazion/Hordeolum) in at least one eye. If both eyes are diagnosed with lid inflammation, both eyes will be treated

In good health (no current or past relevant medical history), based on the judgment of the investigator

Parent/guardian is able and willing to follow instructions and provide informed consent

12 exclusion criteria prevent from participating

Known hypersensitivity to corticosteroids, loteprednol etabonate, or any component of the study medication

Known hypersensitivity to aminoglycosides, tobramycin, or any component of the study medication

Use of concurrent ocular therapy with non-steroidal anti-inflammatory agent (NSAID), mast cell stabilizer, antihistamine, or decongestant within 48 hours before and during the study

Use of oral or topical ophthalmic corticosteroids (other than study medication) within 48 hours before and during the study

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension

Group II

Placebo

Vehicle

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Pediatric Ophthalmology of Erie

Erie, United StatesOpen Pediatric Ophthalmology of Erie in Google Maps

CompletedOne Study Center