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 range

1 Month – 12 Months

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Congenital Nasolacrimal Duct Obstruction trials