Clinical Trial: Pediatric Zylet Safety and Efficacy Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 (Chala

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 Summary:
Sponsor: Bausch & Lomb Incorporated

Current Primary Outcome: Treatment Emergent Adverse Events [ Time Frame: day 1, day 8, day 15 ]

Study eye - Safety Population, At all visits 1,2,3


Original Primary Outcome: Safety (review of adverse events)

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Efficacy (number of study eyes with clinical improvement)

Information By: Bausch & Lomb Incorporated

Dates:
Date Received: January 8, 2007
Date Started: November 2006
Date Completion:
Last Updated: September 30, 2011
Last Verified: September 2011