NCT00300079

Brief Summary

This is a multiple-dose study of the IOP-lowering efficacy of Azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (PGA) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

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

First Submitted

Initial submission to the registry

March 6, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 8, 2006

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

November 18, 2016

Status Verified

June 1, 2008

Enrollment Period

1 year

First QC Date

March 6, 2006

Last Update Submit

November 17, 2016

Conditions

Primary Open Angle GlaucomaOcular Hypertension

Keywords

Ocular Hypertension Patients

Outcome Measures

Primary Outcomes (1)

  • IOP-lowering at 8 and 16 weeks

Secondary Outcomes (1)

  • Safety throughout the 16 weeks of the study

Interventions

brinzolamide 1.0%DRUG

Eligibility Criteria

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

You may qualify if:

  • Primary open angle glaucoma or ocular hypertension patients

You may not qualify if:

  • Women of childbearing potential
  • History of bronchial asthma, or severe chronic obstructive pulmonary disease
  • Presence of acute glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

San Diego, California, United States

Location

Related Publications (1)

  • Liu JH, Medeiros FA, Slight JR, Weinreb RN. Comparing diurnal and nocturnal effects of brinzolamide and timolol on intraocular pressure in patients receiving latanoprost monotherapy. Ophthalmology. 2009 Mar;116(3):449-54. doi: 10.1016/j.ophtha.2008.09.054. Epub 2009 Jan 20.

    PMID: 19157559RESULT

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • John Liu, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2006

First Posted

March 8, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

November 18, 2016

Record last verified: 2008-06

Locations

US(1)