Overview

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

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborator:
Bausch & Lomb Incorporated
Treatments:
7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
Besifloxacin
Fluoroquinolones
Ophthalmic Solutions
Polymyxin B
Polymyxins
Trimethoprim
Criteria
Inclusion Criteria:

- Persons who have been diagnosed with congenital Nasolacrimal Duct Obstruction (NLDO)
with infection by the Principal Investigator

- Both males and females

- Persons who are age of 1 to 12 months at time of diagnosis (time of diagnosis is
defined as when the Principal Investigator makes clinical diagnosis.)

Exclusion Criteria:

- Persons who have received any antibiotic treatment for NLDO with infection for more
than 2 week in the past 4 weeks.

- Persons who are currently receiving systemic antibiotic treatment that cannot be
discontinued.

- Persons with any other ocular anomalies that could potentially interfere with
interpretation of study results.

- Persons who have had any prior nasolacrimal duct system procedures such as stenting or
probing.

- Persons who have previously participated in any clinical trial(s) of Besivance™

- Persons who have participated in any other clinical trial(s) of any investigational
agent(s) within 30 days prior to the Baseline visit

- Persons who have any chronic diseases that might interfere with study participation