NCT00527501

Brief Summary

The purpose of this study is to compare the safety and IOP-lowering efficacy of a fixed combination of Travoprost/Brinzolamide Ophthalmuc Suspension dosed BID and QD, to TRAVATAN dosed QD and a Vehicle dosed BID in 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
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 16, 2012

Status Verified

February 1, 2008

Enrollment Period

4 months

First QC Date

September 10, 2007

Last Update Submit

April 12, 2012

Conditions

Open-angle GlaucomaOcular Hypertension

Keywords

Open-angle glaucomaocular hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean IOP

    Time

Interventions

Travoprost/brinzolamideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients 18 years of age or older of either sex and any race with diagnosed open-angle glaucoma or confirmed ocular hypertension

You may not qualify if:

  • Age (Under 18)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artesia

Artesia, California, 90701, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

Travoprostbrinzolamide

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Theresa Landry

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2007

First Posted

September 11, 2007

Study Start

August 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 16, 2012

Record last verified: 2008-02

Locations

US(1)