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olopatadine/ketorolac tromethamine fixed dose combination

Phase 3

Rhinitis, Allergic, Seasonal | Small molecule | Immunology |AbbVie Inc.|Last Updated: Jan 25, 2012

Target and mechanism

ModalitySmall molecule

Also known as Olopatadine

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment129

FDA Designations

No designations recorded

Clinical trial landscape

olopatadine/ketorolac tromethamine fixed dose combination · 1 trial · 2 indications

Phase 3 1
NCT01258309Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic ConjunctivitisRhinitis, Allergic, Seasonal
COMPLETED129 Analytics
PHASE3COMPLETED
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Rhinitis, Allergic, Seasonal
NCT01258309129
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Study Endpoints

Primary Endpoints

Ocular Itching
Day 21

Secondary Endpoints

Hyperemia
Day 21
Chemosis
Day 21
Ocular mucous discharge
Day 21
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALolopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
2ACTIVE_COMPARATORolopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution

Interventions

NameTypeDescription
olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solutionDRUGOne drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.
olopatadine hydrochloride 0.1% ophthalmic solutionDRUGOne drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.
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Eligibility Criteria

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

Inclusion Criteria: * Clinical diagnosis of seasonal allergic conjunctivitis Exclusion Criteria: * Ocular infection or history of ocular herpes infection * History of retinal detachment or diabetic retinopathy * Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immun...

Countries:India
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