NCT00168363

Brief Summary

This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

May 30, 2011

Status Verified

May 1, 2011

Enrollment Period

1.6 years

First QC Date

September 12, 2005

Last Update Submit

May 27, 2011

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • lowering of intraocular pressure

Interventions

brimonidineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ocular hypertension or glaucoma in both eyes
  • currently treated with brimonidine
  • requires IOP-lowering therapy in both eyes

You may not qualify if:

  • uncontrolled systemic disease
  • known allergy or sensitivity to brimonidine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cantor LB, Safyan E, Liu CC, Batoosingh AL. Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial. Curr Med Res Opin. 2008 Jul;24(7):2035-43. doi: 10.1185/03007990802199287. Epub 2008 Jun 4.

    PMID: 18534052DERIVED

Related Links

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

May 30, 2011

Record last verified: 2011-05