Pediatric Zylet Safety and Efficacy Study

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

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 Overview

• Status: Completed
• Conditions: Hordeolum; Chalazion
• Intervention / Treatment: Drug: loteprednol etabonate/tobramycin opthalmic suspension; Drug: vehicle

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16501
      • Pediatric Ophthalmology of Erie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle	Drug: vehicle; 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.
Experimental: Loteprednol/Tobramycin; 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension	Drug: loteprednol etabonate/tobramycin opthalmic suspension; 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.; Other Names: Zylet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events	Study eye - Safety Population, At all visits 1,2,3	day 1, day 8, day 15

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigators Global Assessment of the Clinical Condition	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.	Visit 3, day 8
Assessment of Ocular Signs in the Study Eye - Visit 1	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.	Visit 1 (day 1)
Assessment of Ocular Signs in the Study Eye - Visit 2	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.	Visit 2 (day 8)
Assessment of Ocular Signs in the Study Eye - Visit 3	Lid edema, lid erythema, palpebral conjunctival injection, meibomium plugging measured on a scale of 0-4 none, minimal, mild, moderate, severe.	Visit 3 (day 15)

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Timothy L Comstock, OD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: January 8, 2007
• First Submitted That Met QC Criteria: January 8, 2007
• First Posted (Estimate): January 11, 2007

Study Record Updates

• Last Update Posted (Estimate): October 7, 2011
• Last Update Submitted That Met QC Criteria: September 30, 2011
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Neoplasms; Eye Diseases; Cysts; Bacterial Infections; Bacterial Infections and Mycoses; Eyelid Diseases; Eye Infections, Bacterial; Eye Infections; Hordeolum; Chalazion; Anti-Infective Agents; Anti-Bacterial Agents; Anti-Allergic Agents; Loteprednol Etabonate; Tobramycin
• Other Study ID Numbers: 459