MedPath

Besifloxacin

Generic Name
Besifloxacin
Brand Names
Besivance
Drug Type
Small Molecule
Chemical Formula
C19H21ClFN3O3
CAS Number
141388-76-3
Unique Ingredient Identifier
BFE2NBZ7NX
Background

Besifloxacin is a fourth generation fluoroquinolone-type opthalmic antibiotic for the treatment of bacterial conjunctivitis. FDA approved on May 28, 2009.

Indication

Treatment of bacterial conjunctivitis. Bacterial isolates that are susceptible to besifloxacin include: CDC coryneform group G; Corynebacterium pseudodiphtheriticum; Corynebacterium striatum; Haemophilus influenzae; Moraxella lacunata; Staphylococcus aureus; Staphylococcus epidermidis; Staphylococcus hominis; Staphylococcus lugdunensis; Streptococcus mitis group; Streptococcus oralis; Streptococcus pneumoniae; Streptococcus salivarius*

Associated Conditions
Bacterial Conjunctivitis

Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-11
Last Posted Date
2012-08-13
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
120
Registration Number
NCT01120418
Locations
🇺🇸

Bausch & Lomb, Rochester, New York, United States

Efficacy of Besifloxacin Ophthalmic Suspension in the Treatment of Bacterial Conjunctivitis

Phase 2
Completed
Conditions
Bacterial Conjunctivitis
Interventions
Drug: Vehicle (Placebo)
First Posted Date
2009-09-09
Last Posted Date
2012-03-29
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
474
Registration Number
NCT00972777
Locations
🇺🇸

Bausch & Lomb Incorporated, Rochester, New York, United States

Study of Ocular Penetration of Topically Administered Fluoroquinolones

First Posted Date
2009-06-19
Last Posted Date
2017-10-24
Lead Sponsor
Johns Hopkins University
Target Recruit Count
50
Registration Number
NCT00924729
Locations
🇺🇸

The Wilmer Eye Institute at Johns Hopkins University, Baltimore, Maryland, United States

Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-05-21
Last Posted Date
2011-12-09
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
119
Registration Number
NCT00905762
Locations
🇺🇸

Bausch & Lomb Incorporated, Rochester, New York, United States

Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects

Phase 1
Completed
Conditions
Cataract Extraction
Interventions
First Posted Date
2009-01-16
Last Posted Date
2011-12-13
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
105
Registration Number
NCT00824070
Locations
🇺🇸

Ophthalmic Consultants of Long Island, Rockville Center, New York, United States

Clinical and Microbial Efficacy of ISV403 in Bacterial Conjunctivitis

Phase 2
Completed
Conditions
Bacterial Conjunctivitis
Interventions
Drug: Vehicle
First Posted Date
2008-02-25
Last Posted Date
2015-03-24
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
270
Registration Number
NCT00622908

Systemic Pharmacokinetics of BOL-303224-A

Phase 1
Completed
Conditions
Conjunctivitis, Bacterial
Interventions
First Posted Date
2006-12-05
Last Posted Date
2011-12-09
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
24
Registration Number
NCT00407589
Locations
🇺🇸

Cornerstone Eyecare, High point, North Carolina, United States

A Study to Determine if 0.6% ISV-403 is Safe and Effective in the Treatment of Bacterial Conjunctivitis.

Phase 3
Completed
Conditions
Acute Bacterial Conjunctivitis
Interventions
Drug: Vehicle
First Posted Date
2006-07-04
Last Posted Date
2015-03-24
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
957
Registration Number
NCT00347932

A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis

Phase 3
Completed
Conditions
Acute Bacterial Conjunctivitis
Interventions
First Posted Date
2006-07-04
Last Posted Date
2015-03-24
Lead Sponsor
Bausch & Lomb Incorporated
Target Recruit Count
1161
Registration Number
NCT00348348
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