CompletedPhase 1

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

United States24 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range1 Month – 12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Physician-rated Scale of NLDO From Baseline to Follow-Up Visit at Week 8 or From Baseline to Time of Treatment Failure, if Earlier.

Timeframe: Baseline to Week 8

Trial details

NCT IDNCT01431170

SponsorRutgers, The State University of New Jersey

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2015-12-23