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Besivance

Phase 3

Bacterial Conjunctivitis | Small molecule | Infectious Disease |Bausch + Lomb Corporation|Last Updated: May 1, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment518

FDA Designations

No designations recorded

Clinical trial landscape

Besivance · 1 trial · 1 indication

Phase 3 1
NCT01175590Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to VehicleBacterial Conjunctivitis
COMPLETED518 Analytics
PHASE3COMPLETED
Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle
Bacterial ConjunctivitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular Treatment Emergent Adverse Events
At each visit - 7 days

Ocular Treatment-Emergent Adverse Events on the Study Eye

Non-Ocular Treatment-Emergent Adverse Events
7 days

Non-Ocular Treatment-Emergent Adverse Events on the Study Eye

Secondary Endpoints

Clinical Resolution
Day 8 (Visit 2)
Microbial Eradication
Days 8 (Visit 2)
Microbial Outcome With Clinical Resolution
Day 8 (Visit 2)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BesivanceEXPERIMENTALbesifloxacin ophthalmic suspension 0.6%
VehiclePLACEBO_COMPARATORVehicle of Besivance

Interventions

NameTypeDescription
BesivanceDRUGOcular administration to affected eye for 7 days
VehicleDRUGVehicle of Besivance administered to affected eye for 7 days
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Eligibility Criteria

Age Range1 Year to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. * Subjects who are willing to discontinue contact lens wear for the duration of the study. * Subjec...

Countries:United States
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Frequently asked questions about Besivance

What is Besivance used for?

Besivance is a small molecule drug developed by Bausch + Lomb Corporation for the treatment of bacterial conjunctivitis and congenital nasolacrimal duct obstruction. It is an ophthalmic suspension containing besifloxacin 0.6%.

Who makes Besivance?

Besivance is developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the drug's safety and efficacy for the treatment of bacterial conjunctivitis and congenital nasolacrimal duct obstruction.

What phase is Besivance in?

Besivance is in Phase 3 clinical development for bacterial conjunctivitis, with a completed Phase 3 trial. It is also being studied in a Phase 1 trial for congenital nasolacrimal duct obstruction. Besivance is investigational and not yet approved by the FDA.

What clinical trials is Besivance in?

Besivance has been studied in two completed clinical trials. NCT01175590 was a Phase 3, randomized, double-blind, placebo-controlled trial in 518 patients with bacterial conjunctivitis. NCT01431170 was a Phase 1 trial in 24 children with congenital nasolacrimal duct obstruction.

Is Besivance the same as besifloxacin?

Besivance is the brand name for besifloxacin ophthalmic suspension 0.6%. The drug contains the active ingredient besifloxacin, which is a fluoroquinolone antibiotic used to treat bacterial infections of the eye.