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

Completed · Phase 1

Conditions studied: Congenital Nasolacrimal Duct Obstruction

In brief

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.

Key facts

Study ID

NCT01431170

Run by

Rutgers, The State University of New Jersey

People needed

24

Starts

2011-09-01

Expected to finish

2014-06-01

Last updated by the study team

2016-07-14

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.)

You may not qualify if…

• 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

Where it is running

• Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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