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

Congenital Nasolacrimal Duct Obstruction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01431170
• Other study ID #: 0120110184
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2011
• Last updated: October 1, 2014
• Start date: September 2011
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Nasolacrimal Duct Obstruction

Intervention

Drug:
• Besivance
Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
• Polytrim
Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.

Locations

Country	Name	City	State
United States	Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the physician-rated scale of NLDO with infection as measured from Baseline to Follow-Up Visit at Week 8 or from Baseline to time of treatment failure, if earlier.	The principal investigator will assess the rating of NLDO with infection in the study eye. The standard photograph set of NLDO with infection will be established before the initiation of the study to ensure the uniformity of the physician's grading process over the course of the study.	Week 8	Yes
Secondary	Recurrence rates of both study (Besivance TM) and control (Polytrim) groups		Baseline to Closeout Visit	No
Secondary	Efficacy of recurrence treatment of both study (Besivance TM) and control (Polytrim) groups measured by the change in the physician- rated scale of NLDO with infection		Baseline to Closeout Visit	No
Secondary	External photo of the study eye		Baseline to Closeout Visit	Yes
Secondary	Dye test of the study eye		Baseline to Closeout Visit	No
Secondary	Treatment failure	Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO with infection is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists.	Baseline to the time of failure	Yes
Secondary	Medication safety outcomes	During each study visit, the Principal Investigator will evaluate any possible adverse events by assessing clinical complaints and symptoms that are experienced by subjects and observed by the parent(s)/legal guardian(s), including findings in external, lacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator, as well as Clinical signs including findings in external, nasolacrimal duct system and anterior segment using slit lamp and fundus exam using indirect ophthalmoscope by principal investigator.	Baseline to Closeout Visit	Yes
Secondary	Treatment Improvement	Defined as improvement as compared to the baseline vist by 1 grade in the physician-grading scale of NLDO with infection	Baseline to closeout	Yes