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

Rutgers The State University of New Jersey

Status and phase

Completed

Phase 1

Conditions

Congenital Nasolacrimal Duct Obstruction

Treatments

Drug: Polytrim Treatment Group

Drug: Besivance Treatment Group

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01431170

0120110184

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

1 to 12 months old

Volunteers

No 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