Patient Preference Comparison of AZARGA Versus COSOPT

Phase 4

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

• Registration Number: NCT01340014
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

Detailed Description

At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-20
• Study First Posted: 2011-04-21
• Study Start: 2011-09
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2013-10-18
• Results First Submitted QC: 2013-10-18
• Results First Posted: 2013-12-13
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Clinical diagnosis of ocular hypertension, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
• On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.
• IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.
• IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).
• Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.
• Able to follow instructions and willing and able to attend all study visits.
• Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form.
• Other protocol-defined inclusion criteria may apply.

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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 clinically significant in the opinion of the Principal Investigator.
• Best corrected visual acuity worse than 20/80 Snellen in either eye.
• Any abnormality preventing reliable applanation tonometry in either eye.
• Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.
• Progressive retinal or optic nerve disease from any cause.
• History of ocular herpes simplex.
• Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker.
• Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control.
• Participation in any other investigational study within 30 days prior to the Screening/baseline Visit.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
COSOPT/AZARGA	Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension	1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
AZARGA/COSOPT	Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension	1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
AZARGA/COSOPT	Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution	1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
COSOPT/AZARGA	Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution	1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.

Primary Outcome Measures

Name	Time	Method
Preferred Treatment	At the end of both periods, Day 15	The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.

Secondary Outcome Measures

Name	Time	Method
Ocular Discomfort	Day 7 of each period	Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).