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Terminated Phase 3 Interventional Results available

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

ClinicalTrials.gov ID: NCT01330355

Public ClinicalTrials.gov record NCT01330355. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01330355
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bausch & Lomb Incorporated
Industry
Enrollment
33 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
1 Day to 31 Days
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2011
Primary completion
Dec 31, 2012
Completion
Sep 30, 2013
Last update posted
Sep 2, 2014

2011 – 2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Bausch & Lomb Incorporated Bridgewater New Jersey 08807

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01330355, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 2, 2014 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01330355 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →