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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00651612

Enrollment

604

Registered

2008-04-03

Start date

2005-11-30

Completion date

2007-01-31

Last updated

2008-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma, Ocular Hypertension

Brief summary

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

Interventions

DRUGBrimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)

DRUGConcurrent brimonidine 0.2% and 0.5% timolol

Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Adverse Events	Day 10

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026