Pediatric Zylet Safety and Efficacy Study
Condition: Chalazion; Hordeolum
MeSH terms: Hordeolum; Chalazion
Intervention: loteprednol etabonate/tobramycin opthalmic suspension; vehicle
Intervention description: 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.; 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.
Intervention MeSH terms: Loteprednol Etabonate; Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Maximum age: 6 Years
Healthy volunteers: No

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)
    

Eligibility 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