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

This study has been completed.
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01431170
First received: September 6, 2011
Last updated: June 15, 2016
Last verified: March 2016

September 6, 2011
June 15, 2016
September 2011
June 2014   (final data collection date for primary outcome 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. [ Time Frame: Baseline to Week 8 ] [ Designated as safety issue: No ]

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.

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. [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01431170 on ClinicalTrials.gov Archive Site
  • Number of Recurrences by Randomization Group [ Time Frame: Baseline to Week 16 (Closeout Visit ) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Baseline to Week 16 (Closeout Visit) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to the time of failure or Week 16 (Closeout Visit) ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Baseline to Week 16 (Closeout Visit ) ] [ Designated as safety issue: Yes ]
    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.
  • Recurrence rates of both study (Besivance TM) and control (Polytrim) groups [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: No ]
  • External photo of the study eye [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: Yes ]
  • Dye test of the study eye [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: No ]
  • Treatment failure [ Time Frame: Baseline to the time of failure ] [ Designated as safety issue: Yes ]
    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.
  • Medication Safety Outcomes [ Time Frame: Baseline to Closeout Visit ] [ Designated as safety issue: Yes ]
    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.
Not Provided
Not Provided
 
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Congenital Nasolacrimal Duct Obstruction
  • Drug: Besivance Treatment Group
    Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
    Other Name: Besifloxacin,Besivance
  • Drug: Polytrim Treatment Group
    Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
    Other Name: polymyxin b/trimethoprim - ophthalmic
  • Experimental: Besivance Treatment Group
    Besivance™ ophthalmic suspension, 0.6%
    Intervention: Drug: Besivance Treatment Group
  • Active Comparator: Polytrim Treatment Group
    Polytrim ophthalmic solution
    Intervention: Drug: Polytrim Treatment Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
1 Month to 12 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01431170
0120110184
Yes
Not Provided
Not Provided
Rutgers, The State University of New Jersey
Rutgers, The State University of New Jersey
Bausch & Lomb Incorporated
Principal Investigator: Suqin Guo, M.D. Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Rutgers, The State University of New Jersey
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP