Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension

The purpose of this study is to assess patient preference of AZARGA® compared to COSOPT® after a single drop of each medication is administered to both eyes, in patients with open-angled glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA); Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Centro Oftalmológico

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:

• Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
• On a stable regimen intraocular pressure (IOP) lowering medication within 30 days of screening visit.
• IOP considered to be safe (in the opinion of the investigator) in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
• Willing to discontinue use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during Screening Visit and for the course of the study.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study that is deemed clinical significant in the opinion of the Principal Investigator.
• Corneal dystrophies in either eye.
• Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
• Bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• History of severe allergic rhinitis.
• Participation in any other investigational study within 30 days prior to the Screening/Baseline Visit.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Azarga/Cosopt; Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Azarga will be instilled one drop in each eye on Day One, after which Cosopt will be administered one drop in each eye on Day Two.	Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA); Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.; Other Names: AZARGA®; Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT); Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.; Other Names: COSOPT®
Active Comparator: Cosopt/Azarga; Following administration of the baseline dose (each intervention instilled in one eye in a contralateral fashion to establish baseline ocular comfort for each medication), Cosopt will be administered one drop in each eye on Day One, after which Azarga will be administered one drop in each eye on Day Two.	Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA); Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.; Other Names: AZARGA®; Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT); Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.; Other Names: COSOPT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Discomfort	One drop of medication will be instilled in each eye. At one minute after instillation, subject will be given an Ocular Discomfort Scale and will record ocular discomfort on a questionnaire using a 10-point scale, with 0 being no discomfort and 09 being substantial discomfort.	One minute after instillation

Collaborators and Investigators

• Sponsor: Alcon Research

Publications and helpful links

General Publications

• https://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 14, 2011
• First Posted (Estimate): November 15, 2011

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: ocular hypertension; Primary open-angle glaucoma; pigment dispersion glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Glaucoma; Ocular 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; Maleic acid; Brinzolamide
• Other Study ID Numbers: SMA-09-18