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0.2% brimonidine/0.5% timolol fixed combination

Phase 3

Glaucoma | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Apr 3, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment432

FDA Designations

No designations recorded

Clinical trial landscape

0.2% brimonidine/0.5% timolol fixed combination · 1 trial · 2 indications

Phase 3 1
NCT00652106Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular HypertensionGlaucoma
COMPLETED432 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension
GlaucomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Intraocular pressure (IOP)
Day 28
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
2ACTIVE_COMPARATORConcurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
3ACTIVE_COMPARATOR0.2% brimonidine ophthalmic solution

Interventions

NameTypeDescription
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solutionDRUG0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solutionDRUGBrimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Brimonidine 0.2% ophthalmic solutionDRUGBrimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
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Eligibility Criteria

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

Inclusion Criteria: * Diagnosis of ocular hypertension or glaucoma * Patient requires IOP-lowering therapy in both eyes Exclusion Criteria: * Uncontrolled medical conditions * Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Countries:United States
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