Pediatric Zylet Safety and Efficacy Study

Bausch + Lomb

Status and phase

Completed

Phase 4

Conditions

Chalazion

Hordeolum

Treatments

Drug: loteprednol etabonate/tobramycin opthalmic suspension

Drug: vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT00420628

459

Details and patient eligibility

About

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)

Enrollment

108 patients

Sex

All

Ages

Under 6 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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
Use of systemic antibiotics within 72 hours before and during the 14 day study medication treatment duration
Use of topical ophthalmic antibiotics (other than the study medication) within 72 hours before and during the study
History of ocular surgery, including laser procedures, within the past six months
Anticipation that surgical intervention for lid inflammation will be required prior to completion of the study
Subjects with suspected vernal conjunctivitis, glaucoma of any kind, viral or bacterial conjunctivitis, preseptal cellulitis requiring systemic antibiotics, dacryocystitis, uveitis, or any other disease conditions that could interfere with the safety and efficacy evaluations of the study medication
History of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study
Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study
Unlikely to comply with the protocol instructions for any reason