NCT00314158

Brief Summary

The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
523

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
5 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
9 months 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
Last Updated

November 18, 2016

Status Verified

March 1, 2012

Enrollment Period

1.2 years

First QC Date

April 10, 2006

Last Update Submit

November 17, 2016

Conditions

Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean intra-ocular pressure (IOP)

Study Arms (3)

Brinzolamide +Timolol

EXPERIMENTAL
Drug: Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspension

Brinzolamide

ACTIVE COMPARATOR
Drug: Brinzolamide 10 mg/ml (AZOPT) eye drops, suspension

Timolol

ACTIVE COMPARATOR
Drug: Timolol 5 mg/ml eye drops, solution

Interventions

Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops, suspensionDRUG

One drop twice daily in each study eye for six months

Brinzolamide +Timolol
Brinzolamide 10 mg/ml (AZOPT) eye drops, suspensionDRUG

One drop twice daily in each study eye for six months

Also known as: AZOPT
Brinzolamide
Timolol 5 mg/ml eye drops, solutionDRUG

One drop twice daily in each study eye for six months

Timolol

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • Diagnosis of open-angle glaucoma

You may not qualify if:

  • Under 18
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United States Investigative Sites

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • Kaback M, Scoper SV, Arzeno G, James JE, Hua SY, Salem C, Dickerson JE, Landry TA, Bergamini MV; Brinzolamide 1%/Timolol 0.5% Study Group. Intraocular pressure-lowering efficacy of brinzolamide 1%/timolol 0.5% fixed combination compared with brinzolamide 1% and timolol 0.5%. Ophthalmology. 2008 Oct;115(10):1728-34, 1734.e1-2. doi: 10.1016/j.ophtha.2008.04.011. Epub 2008 Jun 5.

    PMID: 18538406RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamideTimololOphthalmic SolutionsSuspensionsSolutions

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazinesPharmaceutical SolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of ChemicalsColloidsComplex MixturesDosage Forms

Study Design

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

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 13, 2006

Study Start

November 1, 2005

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

November 18, 2016

Record last verified: 2012-03

Locations

US(1)