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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-06-30

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.

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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.

Conditions

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Congenital Nasolacrimal Duct Obstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Besivance Treatment Group

Besivance™ ophthalmic suspension, 0.6%

Group Type EXPERIMENTAL

Besivance Treatment Group

Intervention Type DRUG

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

Polytrim Treatment Group

Polytrim ophthalmic solution

Group Type ACTIVE_COMPARATOR

Polytrim Treatment Group

Intervention Type DRUG

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

Interventions

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Besivance Treatment Group

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

Intervention Type DRUG

Polytrim Treatment Group

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

Intervention Type DRUG

Other Intervention Names

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Besifloxacin,Besivance polymyxin b/trimethoprim - ophthalmic

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No