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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Congenital Nasolacrimal Duct Obstruction

Intervention / Treatment
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* Drug: Besivance Treatment Group
* Drug: Polytrim Treatment Group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besivance Treatment Group<br>Besivance™ ophthalmic suspension, 0.6% | Drug: Besivance Treatment Group<br>* Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.<br>* Other names: Besifloxacin,Besivance;|
| Active Comparator: Polytrim Treatment Group<br>Polytrim ophthalmic solution | Drug: Polytrim Treatment Group<br>* Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.<br>* Other names: polymyxin b/trimethoprim - ophthalmic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 16 (Closeout Visit ) | 
| 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. | Baseline to Week 16 (Closeout Visit) | 
| 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. | Baseline to the time of failure or Week 16 (Closeout Visit) | 
| 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 Week 16 (Closeout Visit ) |