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KPI-121 1.0%

Phase 3

Ocular Infections, Irritations and Inflammations | Small molecule | Other |KALA BIO, Inc.|Last Updated: Jan 29, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment380

FDA Designations

No designations recorded

Clinical trial landscape

KPI-121 1.0% · 1 trial · 1 indication

Phase 3 1
NCT02163824Safety and Efficacy of KPI-121 in Subjects With Postsurgical InflammationOcular Infections, Irritations and Inflammations
COMPLETED380 Analytics
PHASE3COMPLETED
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
Ocular Infections, Irritations and Inflammations
NCT02163824380
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
PurposeTREATMENT

Interventions

NameTypeDescription
KPI-121 0.25%DRUGKPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
KPI-121 1.0%DRUGKPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
Vehicle of KPI-121 0.25%DRUGPlacebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
Vehicle of KPI-121 1.0%DRUGPlacebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
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