Status:

COMPLETED

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Lead Sponsor:

Alcon Research

Conditions:

Glaucoma

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 o...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

September 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2011

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT01471158

Start Date

September 1 2010

End Date

May 1 2011

Last Update

November 21 2016

Active Locations (1)

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Centro Oftalmológico

Buenos Aires, Argentina, 1425