Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

Allergan

Status and phase: Completed; Phase 3

Conditions: Glaucoma; Ocular Hypertension

Treatments: Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution; Drug: Concurrent brimonidine 0.2% and 0.5% timolol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651612

190342-024T

Details and patient eligibility

About

This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Enrollment: 604 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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604 participants in 2 patient groups

1

Experimental group

Description:

Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

Treatment:

Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

2

Active Comparator group

Description:

Concurrent Brimonidine 0.2% and 0.5% Timolol

Treatment:

Drug: Concurrent brimonidine 0.2% and 0.5% timolol