Pediatric Zylet Safety and Efficacy Study

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: Loteprednol Etabonate; Tobramycin

Criteria

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