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: October 1, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Congenital Nasolacrimal Duct Obstruction
Drug: Besivance
Drug: Polytrim
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Treatment Improvement [ Time Frame: Baseline to closeout ] [ Designated as safety issue: Yes ]
    Defined as improvement as compared to the baseline vist by 1 grade in the physician-grading scale of NLDO with infection


Enrollment: 24
Study Start Date: September 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Besivance
Besivance ophthalmic solution, one drop in the study eye three times a day for ten days
Drug: Besivance
Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
Other Name: Besifloxacin,Besivance
Active Comparator: Polytrim
one drop in the study eye three times a day for ten days
Drug: Polytrim
Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
Other Name: polymyxin b/trimethoprim - ophthalmic

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

Ages Eligible for Study:   1 Month to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431170

Locations
United States, New Jersey
Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Bausch & Lomb Incorporated
Investigators
Principal Investigator: Suqin Guo, M.D. Institute of Ophthalmology and Visual Science, RUTGERS-New Jersey Medical School
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01431170     History of Changes
Other Study ID Numbers: 0120110184
Study First Received: September 6, 2011
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Besifloxacin
Ophthalmic Solutions
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014