NCT00326092

Brief Summary

The purpose of this study is to assess the comfort of a glaucoma therapy 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
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 16, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

November 18, 2016

Status Verified

September 1, 2007

Enrollment Period

3 months

First QC Date

May 12, 2006

Last Update Submit

November 17, 2016

Conditions

Open-angle GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Ocular discomfort

Interventions

Brinzolamide/TimololDRUG

Eligibility Criteria

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

You may qualify if:

  • Adults of either sex and any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Worth and Other Sites

Fort Worth, Texas, 76134, United States

Location

Related Publications (1)

  • Vold SD, Evans RM, Stewart RH, Walters T, Mallick S. A one-week comfort study of BID-dosed brinzolamide 1%/timolol 0.5% ophthalmic suspension fixed combination compared to BID-dosed dorzolamide 2%/timolol 0.5% ophthalmic solution in patients with open-angle glaucoma or ocular hypertension. J Ocul Pharmacol Ther. 2008 Dec;24(6):601-5. doi: 10.1089/jop.2008.0030.

    PMID: 19049301RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamideTimolol

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesThiadiazolesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorpholinesOxazines

Study Officials

  • Julia White

    Study Director

    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

May 12, 2006

First Posted

May 16, 2006

Study Start

May 1, 2006

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

November 18, 2016

Record last verified: 2007-09

Locations

US(1)