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Completed

NCT Number: NCT01431170

Safety and Efficacy Study 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.

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Key information

Conditions

Congenital Nasolacrimal Duct Obstruction

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Newark, New Jersey, 07103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Besivance Treatment Group

Drug

Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.

Other names: Besifloxacin,Besivance

Polytrim Treatment Group

Drug

Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.

Other names: polymyxin b/trimethoprim - ophthalmic

Primary outcomes

  1. 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

    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 outcomes

  1. Number of Recurrences by Randomization Group

    Time frame: Baseline to Week 16 (Closeout Visit )

    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.

  2. Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO

    Time frame: Baseline to Week 16 (Closeout Visit)

    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.

  3. Treatment Failure

    Time frame: Baseline to the time of failure or Week 16 (Closeout Visit)

    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.

  4. Medication Safety Outcomes

    Time frame: Baseline to Week 16 (Closeout Visit )

    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.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • Bausch & Lomb Incorporated

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 9, 2011
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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