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

NCT01330355 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2014-09-03

Study results available
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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).

Conditions

  • Bacterial Conjunctivitis

Interventions

DRUG

Besivance

Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days

DRUG

Gatifloxacin

Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Johnson Varughese · Valeant/Bausch & Lomb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
31 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-01-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01330355 on ClinicalTrials.gov