Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Allergan

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution; Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution; Drug: Brimonidine 0.2% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652106

190342-019T

Details and patient eligibility

About

This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Enrollment: 432 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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432 participants in 3 patient groups

1

Experimental group

Description:

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

Treatment:

Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

2

Active Comparator group

Description:

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

Treatment:

Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

3

Active Comparator group

Description:

0.2% brimonidine ophthalmic solution

Treatment:

Drug: Brimonidine 0.2% ophthalmic solution