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T-PRED

Phase 3

Cataract | Small molecule | Ophthalmology |Bausch + Lomb Corporation|Last Updated: Oct 20, 2020

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 Trials2
Total Enrollment236
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00854061Study of T-PRED(TM) Compared to Pred Forte(R) IIPHASE3 COMPLETED 172 — — Feb 1, 2009Aug 1, 2009Oct 20, 20201 United States
NCT00699803Study of T-PRED(TM) Compared to Pred Forte(R)PHASE2 COMPLETED 64 — — May 1, 2008Aug 1, 2008Sep 25, 20201 United States
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Study Endpoints
Primary Endpoints
Means Aqueous Humor Prednisolone Acetate Concentration
35 days
Mean Aqueous Humor Prednisolone Acetate Concentration
4 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
T-PredEXPERIMENTALTobramycin prednisolone acetate combination
Pred ForteACTIVE_COMPARATORPrednisolone acetate
Interventions
NameTypeDescription
T-PredDRUGsterile ophthalmic solution
Pred ForteDRUGsterile ophthalmic solution
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 18 years of age or older Exclusion Criteria: * No active or adverse disease

Countries:United States
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