NCT00652483

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
433

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2003

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

May 1, 2003

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2008

Completed
Last Updated

April 3, 2008

Status Verified

April 1, 2008

Enrollment Period

7 months

First QC Date

April 1, 2008

Last Update Submit

April 1, 2008

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Intraocular pressure (IOP)

    Week 2 - Month 3

Secondary Outcomes (1)

  • IOP

    Month 6 - Month 12

Study Arms (2)

1

EXPERIMENTAL

Brimonidine ophthalmic solution 0.1%

Drug: Brimonidine ophthalmic solution 0.1%

2

ACTIVE COMPARATOR

Brimonidine ophthalmic solution 0.2%

Drug: Brimonidine ophthalmic solution 0.2%

Interventions

Brimonidine ophthalmic solution 0.1%DRUG

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

1
Brimonidine ophthalmic solution 0.2%DRUG

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

Also known as: ALPHAGAN®
2

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

You may not qualify if:

  • Uncontrolled systemic disease
  • Known allergy or sensitivity to brimonidine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Atlanta, Georgia, United States

Location

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 Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 3, 2008

Study Start

May 1, 2003

Primary Completion

December 1, 2003

Study Completion

September 1, 2004

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

US(1)