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NCT01330355 · ClinicalTrials.gov registry record · Phase 3
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
A Phase 3 study, sponsored by Bausch & Lomb Incorporated.
- Terminated
- Registry status
- Phase 3
- Development phase
- 33
- Enrollment target
NCT01330355: Clinical Trial Phase 3 study, sponsored by Bausch & Lomb Incorporated.
NCT01330355 is a Phase 3 study that was terminated before completion, run by Bausch & Lomb Incorporated. The registered enrollment target is 33 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01330355, a Phase 3 study, was terminated before completion, sponsored by Bausch & Lomb Incorporated.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 33 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).
Primary Outcome
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Interventions
- DRUG Gatifloxacin
- DRUG Besivance
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2011-05 |
| Est. Completion | 2013-10 |
| Phase | Phase 3 |
Why NCT01330355 stopped before completion
NCT01330355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Gatifloxacin is the first listed.
NCT01330355 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01330355 about?
NCT01330355 is a clinical study titled "Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis". The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomiza...
What is the current status of trial NCT01330355?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 33 participants. The study started on 2011-05. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01330355?
The interventions under investigation include: Gatifloxacin (DRUG), Besivance (DRUG).
Who is sponsoring clinical trial NCT01330355?
This trial is sponsored by Bausch & Lomb Incorporated, which has 174 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01330355's enrollment target sits among peer trials
33 1907th of 2000 higher than 92 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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