NCT00651612

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2005

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

November 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
1.2 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

1.2 years

First QC Date

April 1, 2008

Last Update Submit

April 1, 2008

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Day 10

Study Arms (2)

1

EXPERIMENTAL

Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution

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

2

ACTIVE COMPARATOR

Concurrent Brimonidine 0.2% and 0.5% Timolol

Drug: Concurrent brimonidine 0.2% and 0.5% timolol

Interventions

Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic SolutionDRUG

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

Also known as: COMBIGAN™
1
Concurrent brimonidine 0.2% and 0.5% timololDRUG

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)

2

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of ocular hypertension or glaucoma
  • Patient requires IOP-lowering therapy in both eyes

You may not qualify if:

  • Uncontrolled medical conditions
  • Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Newport Beach, California, United States

Location

Related Links

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Brimonidine TartrateTimololBrimonidine Tartrate, Timolol Maleate Drug Combination

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingMorpholinesOxazinesDrug CombinationsPharmaceutical Preparations

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

November 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

April 3, 2008

Record last verified: 2008-04

Locations

US(1)