Status:
COMPLETED
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Bausch & Lomb Incorporated
Conditions:
Congenital Nasolacrimal Duct Obstruction
Eligibility:
All Genders
1-12 years
Phase:
PHASE1
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01431170
Start Date
September 1 2011
End Date
June 1 2014
Last Update
July 14 2016
Active Locations (1)
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1
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Newark, New Jersey, United States, 07103