Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

• The change in the physician-rated scale of NLDO with infection as measured from Baseline to Follow-Up Visit at Week 8 or from Baseline to time of treatment failure, if earlier. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
  The principal investigator will assess the rating of NLDO with infection in the study eye. The standard photograph set of NLDO with infection will be established before the initiation of the study to ensure the uniformity of the physician's grading process over the course of the study.
  
  

• Recurrence rates of both study (Besivance TM) and control (Polytrim) groups [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: No ]
  
• Efficacy of recurrence treatment of both study (Besivance TM) and control (Polytrim) groups measured by the change in the physician- rated scale of NLDO with infection [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: No ]
  
• External photo of the study eye [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: Yes ]
  
• Dye test of the study eye [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: No ]
  
• Treatment failure [ Time Frame: Baseline to the time of failure ] [ Designated as safety issue: Yes ]
  Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO with infection is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.
  
  
• Medication safety outcomes [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: Yes ]
  During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as Clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.
  
  

The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO) to follow-up visit #2 or at the time of treatment failure, if earlier.