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Gatifloxacin

Phase 1

Healthy | Small molecule | Other |Bausch + Lomb Corporation|Last Updated: Dec 9, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment119
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00905762Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical InstillationPHASE1 COMPLETED 119Mar 1, 2009Apr 1, 2009Dec 9, 20111 United States
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Study Endpoints
Primary Endpoints
Concentration of besifloxacin, gatifloxacin or moxifloxacin in conjunctival tissue.
Biopsies collected at specified time points from 15 minutes to 24 hours
Secondary Endpoints
Visual acuity
Day -14 through Day 6(+/-1)
Slit Lamp Biomicroscopy
Day -14 through Day 6 (+/-)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSCREENING
Treatment Arms
ArmTypeDescription
BesifloxacinEXPERIMENTALBesifloxacin one drop instilled into study eye.
GatifloxacinACTIVE_COMPARATORGatifloxacin one drop instilled into study eye.
MoxifloxacinACTIVE_COMPARATORMoxifloxacin one drop instilled into study eye.
Interventions
NameTypeDescription
GatifloxacinDRUGGatifloxacin 0.3% one drop instilled into study eye at visit 2.
MoxifloxacinDRUGMoxifloxacin 0.5% one drop instilled into study eye at visit 2.
BesifloxacinDRUGBesifloxacin 0.6% one drop instilled into study eye at visit 2.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Willing to avoid all disallowed medications for the appropriate washout periods. * Have a best corrected visual acuity of 0.60 logMAR or better in each eye as measured using an ETDRS chart. Exclusion Criteria: * Have a known allergy and/or sensitivity to the test articles or...

Countries:United States
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