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.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: Azarga (brinzolamide 1% / timolol 0.5%); Drug: Cosopt (dorzolamide 2% / timolol 0.5%)

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5L 1W8

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must be at least 18 years of age.
2. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
3. 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.
4. 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.
5. Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
6. 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:

1. 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.
2. Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
3. Any abnormality preventing reliable applanation tonometry in study eye(s).
4. Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
5. Progressive retinal or optic nerve disease from any cause.
6. 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.
7. 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.
8. Participation in any other investigational study within 30 days prior to Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Azarga; Azarga (brinzolamide 1% / timolol 0.5%)	Drug: Azarga (brinzolamide 1% / timolol 0.5%); Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
Active Comparator: Cosopt; Cosopt (dorzolamide 2% / timolol 0.5%)	Drug: Cosopt (dorzolamide 2% / timolol 0.5%); Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)	12 weeks

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 26, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Timolol; Dorzolamide; Brinzolamide
• Other Study ID Numbers: SMA-09-17