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OpenTrials
Completed

NCT Number: NCT01471158

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centro Oftalmológico

Buenos Aires, 1425, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Drug

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®

Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

Drug

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®

Primary outcomes

  1. Discomfort

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 15, 2011
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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