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Tobradex ST

Phase 3

Blepharitis | Small molecule | Other |Alcon Inc.|Last Updated: Jun 11, 2012

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment122
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01102244A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic BlepharitisPHASE3 COMPLETED 122Apr 1, 2010 -Jun 11, 20121 United States
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Study Endpoints
Primary Endpoints
Global sign and symptom score for blepharitis
Day 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Tobradex STEXPERIMENTALtobramycin 0.3%, dexamethasone 0.05%
AzasiteACTIVE_COMPARATORazithromycin 1%
Interventions
NameTypeDescription
Tobradex STDRUGtobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days
AzasiteDRUGazithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Have diagnosis of moderate to severe chronic blepharitis defined by a minimum score of at least "1" for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye * Have a minimum global score (the total signs and symptoms score) of 5 in t...

Countries:United States
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Competitive Landscape -Blepharitis 2 trials
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