Conditions: Congenital Nasolacrimal Duct Obstruction
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

Brief summary:
The goal of the study is to evaluate the application of Besivance™ (besifloxacin ophthalmic suspension, 0.6%) to treat congenital nasolacrimal duct obstruction in children. The hypothesis of the study is that Besivance™ is as safe and effective as the current standard of care for the treatment of nasolacrimal duct obstruction in children.

Detailed description:
The primary objective of this study is to evaluate the safety and efficacy of Besivance™ as an antibiotic treatment for congenital nasolacrimal duct obstruction with infection in children. The primary outcome measure is the change from baseline on the physician rated scale of Nasolacrimal Duct Obstruction (NLDO)with infection to follow-up visit #2 (Week 8) or at the time of treatment failure, if earlier.

Arms:
arm 1: Besivance™ ophthalmic suspension, 0.6% arm 2: Polytrim ophthalmic solution

Interventions: intervention 1: Besivance Treatment Group intervention 2: Polytrim Treatment Group
Intervention descriptions: intervention 1: Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days. intervention 2: Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.

Protocol document: