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Tobradex AF

Phase 3

Cataract | Small molecule | Ophthalmology |Alcon Inc.|Last Updated: Jul 29, 2008

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment900
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00473070A Clinical Study of Tobradex AFPHASE3 COMPLETED 900 — — Nov 1, 2006 -Jul 29, 20081 United States
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Study Endpoints
Primary Endpoints
Concentration of dexamethasone in aqueous humor following a single topical ocular administration
Periodic
Secondary Endpoints
Changes in external and internal ocular structures, intraocular pressure, vision and other side effects
Periodic
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Tobradex AFDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Adult patients requiring cataract surgery Exclusion Criteria: * Age related

Countries:United States
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