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

CompletadoFase 4ClinicalTrials.gov

ID: NCT01471158Tipo: INTERVENTIONALInicio: 1 de sept de 2010Fin estimado: 1 de may de 2011

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

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.

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.

Ubicaciones

Centro Oftalmológico

Buenos Aires, Argentina

Patrocinadores

PrincipalAlcon Research

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