Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Alcon

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT); Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01471158

SMA-09-18

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Azarga/Cosopt

Active Comparator group

Description:

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.

Treatment:

Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

Cosopt/Azarga

Active Comparator group

Description:

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.

Treatment:

Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)