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

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.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mississauga, Ontario, L5L 1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azarga (brinzolamide 1% / timolol 0.5%)

Drug

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

Cosopt (dorzolamide 2% / timolol 0.5%)

Drug

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

Primary outcomes

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

Time frame: 12 weeks

Secondary outcomes

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

Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 28, 2010
Registry last updated: Jul 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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