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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 is a Phase 3 study that was terminated before completion, run by Bausch & Lomb Incorporated. The registered enrollment target is 33 participants.

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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).

Interventions

  • DRUG Gatifloxacin
  • DRUG Besivance

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2011-05
Est. Completion 2013-10
Phase Phase 3

Sponsor

Bausch & Lomb Incorporated

174 total trials

What the Registry Record Tells You About NCT01330355

The ClinicalTrials.gov registry entry for NCT01330355 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch & Lomb Incorporated, which has 174 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Gatifloxacin is the first listed.

NCT01330355 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.