Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT01471158

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

15.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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®

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)

Other Names:

AZARGA®

Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

Other Names:

COSOPT®

Outcome Measures

Primary Outcome Measures

Discomfort [One minute after instillation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.