Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma
NCT ID: NCT01471158
Last Updated: 2016-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2010-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Abayomi Ogundele, PharmD
Role: STUDY_DIRECTOR
Alcon Research
Locations
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Centro Oftalmológico
Buenos Aires, , Argentina
Countries
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References
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https://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH
Other Identifiers
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SMA-09-18
Identifier Type: -
Identifier Source: org_study_id