Pediatric Zylet Safety and Efficacy Study

Phase 4

Completed

Conditions: Chalazion
Hordeolum

Interventions: Drug: loteprednol etabonate/tobramycin opthalmic suspension
Drug: vehicle

Registration Number: NCT00420628

Lead Sponsor: Bausch & Lomb Incorporated

Brief 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)

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 108

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol/Tobramycin	loteprednol etabonate/tobramycin opthalmic suspension	0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
Vehicle	vehicle	Vehicle

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events	day 1, day 8, day 15	Study eye - Safety Population, At all visits 1,2,3

Secondary Outcome Measures

Name	Time	Method
Investigators Global Assessment of the Clinical Condition	Visit 3, day 8	The efficacy endpoints for this study consisted of reduction of inflammation as measured by the IGA of the clinical condition. Changes in clinical condition measured as improved, unchanged or worsened.
Assessment of Ocular Signs in the Study Eye - Visit 1	Visit 1 (day 1)	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Assessment of Ocular Signs in the Study Eye - Visit 2	Visit 2 (day 8)	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.
Assessment of Ocular Signs in the Study Eye - Visit 3	Visit 3 (day 15)	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.