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

A Prospective, Double-Blinded, Parallel-Group, Randomized Study to Assess the Safety and Efficacy of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children

NCT01431170•Rutgers, The State University of New Jersey

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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.

Eligibility

Age

0 - 1 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School

Newark, New Jersey, United States

Key Dates

Start Date

September 1, 2011

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

July 14, 2016

Enrollment

ACTUAL participants

Conditions

Congenital Nasolacrimal Duct Obstruction

Interventions

Besivance Treatment Group

DRUG

Polytrim Treatment Group

DRUG

Improving the Follow up Rate for Pediatric Patients

NCT04837534

CNLDO - Congenital Nasolacrimal Duct ObstructionAmblyopia+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 14, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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