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Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Azarga (brinzolamide 1% / timolol 0.5%)

Cosopt (dorzolamide 2% / timolol 0.5%)

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azarga

Cosopt

Arm Description

Azarga (brinzolamide 1% / timolol 0.5%)

Cosopt (dorzolamide 2% / timolol 0.5%)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01111890

First Posted

April 26, 2010

Last Updated

July 27, 2015

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01111890

Brief Title

Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Azarga

Arm Type

Experimental

Arm Description

Azarga (brinzolamide 1% / timolol 0.5%)

Arm Title

Cosopt

Arm Type

Active Comparator

Arm Description

Cosopt (dorzolamide 2% / timolol 0.5%)

Intervention Type

Drug

Intervention Name(s)

Azarga (brinzolamide 1% / timolol 0.5%)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cosopt (dorzolamide 2% / timolol 0.5%)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2. 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.

Facility Information:

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5L 1W8

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

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