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Bromfenac

Phase 3

Allergic Conjunctivitis | Small molecule | Other |Bausch + Lomb Corporation|Last Updated: Mar 14, 2013

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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00423007Efficacy and Safety of Topical Bromfenac Ophthalmic Solution vs. Placebo in Subjects With Allergic ConjunctivitisPHASE3 COMPLETED 90Nov 1, 2006Aug 1, 2007Mar 14, 20131 United States
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Study Endpoints
Primary Endpoints
Treatment of ocular itching
Secondary Endpoints
Treatment of chemosis, episcleral and ciliary hyperemia, ocular mucous discharge, eyelid swelling, foreign body sensation, nasal symptoms, and/or tearing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BromfenacEXPERIMENTALOphthalmic Solution
PlaceboPLACEBO_COMPARATORVehicle ophthalmic solution
Interventions
NameTypeDescription
BromfenacDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range10 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * History of clinically active allergic conjunctivitis * Agree to return for all required visits * Agree to avoid disallowed meds Exclusion Criteria: * Known hypersensitivity to bromfenac and salicylates

Countries:United States
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