CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
Besivance Treatment Group +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01431170
NCT01431170Phase 1Completed
CompareCT.gov

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

Rutgers, The State University of New Jersey·interventional·Posted Sep 9, 2011·Updated Jul 14, 2016

In Brief

A Phase 1 clinical trial evaluating Besivance Treatment Group and Polytrim Treatment Group for Congenital Nasolacrimal Duct Obstruction. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Nasolacrimal Duct Obstruction
CountriesUnited States
CollaboratorsBausch & Lomb Incorporated

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 9, 2011
Enrollment StartSep 1, 2011
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.8 years ago

Interventions

Besivance Treatment Groupdrug

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

Polytrim Treatment Groupdrug

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