Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652483

Enrollment

433

Registered

2008-04-03

Start date

2003-05-31

Completion date

2004-09-30

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 and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Interventions

DRUGBrimonidine ophthalmic solution 0.1%

1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

DRUGBrimonidine ophthalmic solution 0.2%

1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

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

* Ocular hypertension or glaucoma in both eyes

Exclusion criteria

* Uncontrolled systemic disease * Known allergy or sensitivity to brimonidine

Design outcomes

Primary

Measure	Time frame
Intraocular pressure (IOP)	Week 2 - Month 3

Secondary

Measure	Time frame
IOP	Month 6 - Month 12

Countries

United States

Outcome results

None listed

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