Clinical trial NCT01431170: Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Nasolacrimal Duct Obstruction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2011-09-09
Enrollment: 24
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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 criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: Number of Recurrences by Randomization Group
timeFrame: Baseline to Week 16 (Closeout Visit )
measure: Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO
timeFrame: Baseline to Week 16 (Closeout Visit)
measure: Treatment Failure
timeFrame: Baseline to the time of failure or Week 16 (Closeout Visit)
measure: Medication Safety Outcomes
timeFrame: Baseline to Week 16 (Closeout Visit )
Other outcomes:
Locations:
city: Newark
country: United States
facility: Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
state: New Jersey
Study officials:
affiliation: Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
name: Suqin Guo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: