Pediatric Zylet Safety and Efficacy Study

Overview

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)

Full Title of 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2009

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Experimental: Loteprednol/Tobramycin
    • 0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension
  • Placebo Comparator: Vehicle
    • Vehicle

Clinical Trial Outcome Measures

Primary Measures

  • Treatment Emergent Adverse Events
    • Time Frame: day 1, day 8, day 15
    • Study eye – Safety Population, At all visits 1,2,3

Secondary Measures

  • Investigators Global Assessment of the Clinical Condition
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bausch & Lomb Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Timothy L Comstock, OD, Study Director, Bausch & Lomb Incorporated

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