Phase 1
N=24
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
Congenital Nasolacrimal Duct Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT01431170 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: 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. — 7; 10; 1; 1 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Besivance Treatment Group (Drug); Polytrim Treatment Group (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
7; 10; 1; 1; 1; 0 | — |
| SECONDARY Number of Recurrences by Randomization Group |
1; 1 | — |
| SECONDARY Efficacy of Recurrence Treatment as Measured by Change in the Physician- Rated Scale of NLDO |
1; 0; 0; 1 | — |
| SECONDARY Treatment Failure |
1; 1 | — |
| SECONDARY Medication Safety Outcomes |
0; 0 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01431170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.