NCT00382226

Brief Summary

Uncontrolled glaucoma patients being treated with a prostaglandin agent alone or in combination with adjunctive drugs in fixed or unfixed combinations, will be switched from their current therapy to travoprost/timolol fixed combination and either Azopt or placebo

Trial Health

87
On Track

Trial Health Score

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

Enrollment
195

participants targeted

Target at P50-P75 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

Study Start

First participant enrolled

September 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2006

Completed
10 months 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

April 1, 2008

Enrollment Period

11 months

First QC Date

September 27, 2006

Last Update Submit

November 17, 2016

Conditions

Glaucoma

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • IOP lowering

Secondary Outcomes (1)

  • safety

Interventions

AzoptDRUG

Eligibility Criteria

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

You may qualify if:

  • Glaucoma

You may not qualify if:

  • Under 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Study Site

Sydney, New South Wales, 2000, Australia

Location

Related Publications (1)

  • Goldberg I, Crowston JG, Jasek MC, Stewart JA, Stewart WC; ADAPT Study Investigator Group. Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy. J Glaucoma. 2012 Jan;21(1):55-9. doi: 10.1097/IJG.0b013e3181fc8142.

    PMID: 21048504RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

brinzolamide

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Mark Jasek

    Alcon Research

    STUDY DIRECTOR

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

September 27, 2006

First Posted

September 28, 2006

Study Start

September 1, 2006

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

November 18, 2016

Record last verified: 2008-04

Locations

AU(1)