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ketorolac eye

Phase 3

Cataract Extraction | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Oct 1, 2009

Target and mechanism

ModalitySmall molecule

Also known as ketorolac eye drops

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment263

FDA Designations

No designations recorded

Clinical trial landscape

ketorolac eye · 1 trial · 1 indication

Phase 3 1
NCT00521456A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract SurgeryCataract Extraction
COMPLETED263 Analytics
PHASE3COMPLETED
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Cataract Extraction
NCT00521456263
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Study Endpoints

Primary Endpoints

Resolution of Post Operative Inflammation
Day 14

Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)

Secondary Endpoints

Ocular Pain
Day 1
Mean Pupil Area
Day 0
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ketorolac eye dropsDRUG1 drop twice daily day preop and Days 1-14, and 6 doses on surgery day Placebo
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients undergoing cataract surgery Exclusion Criteria: * Uncontrolled ocular disease in cataract surgery eye

Countries:United States
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