Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01471158
First received: November 10, 2011
Last updated: July 19, 2012
Last verified: November 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Discomfort [ Time Frame: One minute after instillation ] [ Designated as safety issue: No ]
    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.


Enrollment: 120
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: COSOPT®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01471158

Locations
Argentina
Centro Oftalmológico
Buenos Aires, Argentina, 1425
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Abayomi Ogundele, PharmD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01471158     History of Changes
Other Study ID Numbers: SMA-09-18
Study First Received: November 10, 2011
Last Updated: July 19, 2012
Health Authority: Argentina: Human Research Bioethics Committee

Keywords provided by Alcon Research:
Primary open-angle glaucoma
ocular hypertension
pigment dispersion glaucoma

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Dorzolamide
Maleic acid
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014