NCT00314171

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

100
On Track

Trial Health Score

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

Enrollment
437

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 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

October 1, 2005

Completed
6 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
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

March 1, 2012

Enrollment Period

1.8 years

First QC Date

April 10, 2006

Last Update Submit

November 17, 2016

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

open-angle glaucomaocular hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean IOP

Secondary Outcomes (1)

  • Percent patients with IOP < 18 mmHg

Study Arms (2)

Brinzolamide + Timolol

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

Dorzolamide + Timolol

ACTIVE COMPARATOR
Drug: Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)

Interventions

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

One drop in the study eye(s) twice daily for 12 months

Brinzolamide + Timolol
Dorzolamide 20 mg/ml + Timolol 5 mg/ml eye drops, solution (COSOPT)DRUG

One drop in the study eye(s) twice daily for 12 months

Also known as: COSOPT
Dorzolamide + Timolol

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Diagnosis of open-angle glaucoma or ocular hypertension

You may not qualify if:

  • Under 18
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Manni G, Denis P, Chew P, Sharpe ED, Orengo-Nania S, Coote MA, Laganovska G, Volksone L, Zeyen T, Filatori I, James J, Aung T. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009 Apr-May;18(4):293-300. doi: 10.1097/IJG.0b013e31818fb434.

    PMID: 19365194RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamideTimololOphthalmic SolutionsSuspensionsdorzolamideSolutionsdorzolamide-timolol combination

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

October 1, 2005

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 18, 2016

Record last verified: 2012-03