NCT01111890

Brief Summary

Subjects are dosed twice daily at 9AM and 9PM for 12 weeks. The primary efficacy variable is the mean change in Intraocular Pressure (IOP) from baseline to 12 weeks. Secondary efficacy variable: % IOP ≤ 18 millimeters mercury (mmHg). Exploratory endpoint: Ocular discomfort scale after first dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2010

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

April 1, 2010

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

July 29, 2015

Status Verified

January 1, 2012

Enrollment Period

1.2 years

First QC Date

April 26, 2010

Last Update Submit

July 27, 2015

Conditions

GlaucomaOcular Hypertension

Outcome Measures

Primary Outcomes (1)

  • Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing

    12 weeks

Secondary Outcomes (1)

  • Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)

    12 weeks

Study Arms (2)

Azarga

EXPERIMENTAL

Azarga (brinzolamide 1% / timolol 0.5%)

Drug: Azarga (brinzolamide 1% / timolol 0.5%)

Cosopt

ACTIVE COMPARATOR

Cosopt (dorzolamide 2% / timolol 0.5%)

Drug: Cosopt (dorzolamide 2% / timolol 0.5%)

Interventions

Azarga (brinzolamide 1% / timolol 0.5%)DRUG

Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks

Azarga
Cosopt (dorzolamide 2% / timolol 0.5%)DRUG

Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks

Cosopt

Eligibility Criteria

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

You may qualify if:

  • Must be at least 18 years of age.
  • Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
  • Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
  • Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
  • Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
  • For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.

You may not qualify if:

  • Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
  • Any abnormality preventing reliable applanation tonometry in study eye(s).
  • Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study.
  • A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
  • Participation in any other investigational study within 30 days prior to Visit 1.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Mississauga, Ontario, L5L 1W8, Canada

Location

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

Azargabrinzolamidedorzolamide-timolol combinationdorzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

July 29, 2015

Record last verified: 2012-01

Locations

CA(1)