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

Primary Purpose

Congenital Nasolacrimal Duct Obstruction

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Besivance Treatment Group
Polytrim Treatment Group
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Nasolacrimal Duct Obstruction

Eligibility Criteria

1 Month - 12 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Besivance Treatment Group

Polytrim Treatment Group

Arm Description

Besivance™ ophthalmic suspension, 0.6%

Polytrim ophthalmic solution

Outcomes

Primary Outcome Measures

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.
The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4: 0: No tearing and discharge. 1: Tearing, moderate mucous discharge around nasolacrimal punctum 2: Moderate redness of the medial eyelid with mucous discharge 3: Redness and swelling of the eyelid with mucopurulent discharge 4: Redness and swelling of eyelid with purulent discharge Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following: Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit. Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit. Treatment Failure: grade is worse than or same as the baseline visit.

Secondary Outcome Measures

Number of Recurrences by Randomization Group
Recurrence is defined as when the NLDO with infection in the subject's study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit. Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group.
Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO
Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as "Treatment Success" or "Treatment Failure" according to study protocol.
Treatment Failure
Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists. Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care.
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.

Full Information

First Posted
September 6, 2011
Last Updated
June 15, 2016
Sponsor
Rutgers, The State University of New Jersey
Collaborators
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01431170
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Nasolacrimal Duct Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Besivance Treatment Group
Arm Type
Experimental
Arm Description
Besivance™ ophthalmic suspension, 0.6%
Arm Title
Polytrim Treatment Group
Arm Type
Active Comparator
Arm Description
Polytrim ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Besivance Treatment Group
Other Intervention Name(s)
Besifloxacin,Besivance
Intervention Description
Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Intervention Type
Drug
Intervention Name(s)
Polytrim Treatment Group
Other Intervention Name(s)
polymyxin b/trimethoprim - ophthalmic
Intervention Description
Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Primary Outcome Measure Information:
Title
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.
Description
The NLDO grading scale in the study eye at every visit. The scale ranges from 0 to +4: 0: No tearing and discharge. 1: Tearing, moderate mucous discharge around nasolacrimal punctum 2: Moderate redness of the medial eyelid with mucous discharge 3: Redness and swelling of the eyelid with mucopurulent discharge 4: Redness and swelling of eyelid with purulent discharge Due to varying baseline severity (measured by NLDO grade) among subjects, change from baseline to week 8 in NLDO grade was further classified as the following: Treatment success: grade of 0 or improvement by 2 or more compared to the prior visit. Recurrence: NLDO with infection returns in the study eye, as indicated by a NLDO grade >0 after a grade of 0 at the prior visit. Treatment Failure: grade is worse than or same as the baseline visit.
Time Frame
Baseline to Week 8
Secondary Outcome Measure Information:
Title
Number of Recurrences by Randomization Group
Description
Recurrence is defined as when the NLDO with infection in the subject's study eye returns, as indicated by a NLDO grading scale of greater than zero after achieving a grade of zero at the previous visit. Number of subjects who had a recurrence event of the subjects who completed the study by treatment Group.
Time Frame
Baseline to Week 16 (Closeout Visit )
Title
Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO
Description
Subjects who experience recurrence were re-treated as if they were a new patient, with the same study medication, were followed up then classified as "Treatment Success" or "Treatment Failure" according to study protocol.
Time Frame
Baseline to Week 16 (Closeout Visit)
Title
Treatment Failure
Description
Possible treatment failure at a follow-up examination is operationally defined as follows: if the physician-grading scale of NLDO is worse than or same as the prior visit at any given follow-up visit, possible treatment failure then exists. Treatment Failure occurred if at visit #1 (2-week visit), the physician-grading scale of NLDO is worse than or same as the baseline visit. Treatment failure can also occur at recurrence visit #1 if the NLDO grading scale is worse or the same as compared to the previous visit. Subjects who meet the criteria for treatment failure were withdrawn from the study by the principal investigator and no additional data was collected. Subjects were referred for continued care.
Time Frame
Baseline to the time of failure or Week 16 (Closeout Visit)
Title
Medication Safety Outcomes
Description
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.
Time Frame
Baseline to Week 16 (Closeout Visit )

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suqin Guo, M.D.
Organizational Affiliation
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

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

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