NCT00621335

Brief Summary

The objective of this research study is to compare the tolerability and effectiveness of Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the treatment of 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
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Shorter than P25 for all trials

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

March 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2008

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

February 13, 2008

Last Update Submit

February 22, 2013

Conditions

Open Angle GlaucomaOcular Hypertension

Keywords

Open angle glaucomaOcular hypertensionParallel comparisonCombiganCosopt

Outcome Measures

Primary Outcomes (1)

  • Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension

    12 weeks

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • open angle glaucoma or ocular hypertension including pseudo-exfoliation and pigmentary glaucoma
  • definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss
  • a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination
  • an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline

You may not qualify if:

  • any other form of glaucoma other than primary open angle glaucoma
  • a gonioscopy measured angle grade of less than 2
  • a visual field defect not of glaucomatous origen
  • previous history of cyclodestructive procedures
  • the use of ocular non steroidal and anti-inflammatory topical agent that inhibit cyclooxygenase and prostaglandin analog synthesis
  • the use of glucocorticoid therapy
  • hypersensitivity to any of the study components
  • any ocular laser therapy within the past three months
  • ocular inflammation or infection in the past three months
  • any history of trauma in the last six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Consultants Centres

Mississauga, Ontario, L4W 1W9, Canada

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleOcular Hypertension

Condition Hierarchy (Ancestors)

GlaucomaEye Diseases

Study Officials

  • David Yan, M.D.

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. David Yan M.D, F.R.C.S (c)

Study Record Dates

First Submitted

February 13, 2008

First Posted

February 22, 2008

Study Start

March 1, 2007

Primary Completion

February 1, 2008

Study Completion

February 1, 2008

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

CA(1)