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NCT01431170 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children
A Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01431170: Completed Phase 1 study, sponsored by Rutgers, The State University of New Jersey.
NCT01431170 is a Phase 1 study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431170, a Phase 1 study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Besivance Treatment Group
- DRUG Polytrim Treatment Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT01431170 record still lists
NCT01431170 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Besivance Treatment Group is the first listed.
NCT01431170 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431170 about?
NCT01431170 is a clinical study titled "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 na...
What is the current status of trial NCT01431170?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01431170?
The interventions under investigation include: Besivance Treatment Group (DRUG), Polytrim Treatment Group (DRUG).
Who is sponsoring clinical trial NCT01431170?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01431170's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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