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Completed

NCT Number: NCT01340014

Patient Preference Comparison of AZARGA Versus COSOPT

The purpose of this study was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

At the Screening Visit, each intervention was instilled in one eye in a contralateral fashion to establish baseline ocular comfort prior to randomization. A 48-hour washout period separated the two treatment periods.

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, open-angle with or without pseudoexfoliation or pigment dispersion glaucoma in both eyes.
  • On a stable regimen of intraocular pressure-lowering (IOP) medication within 30 days of Screening Visit.
  • IOP considered safe (in the opinion of the Investigator) in both eyes in such a way that assures clinical stability of vision and the optic nerve throughout the study period.
  • IOP between 19 and 35 millimeters mercury (mmHg) in at least one eye (study eye).
  • Willing to discontinue the use of all other ocular drugs (prescribed and over-the-counter) prior to receiving the screening dose during the Screening Visit and for the entire course of the study.
  • Able to follow instructions and willing and able to attend all study visits.
  • Read, sign, and date an Ethics Committee reviewed and approved Informed Consent Form.
  • 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 clinically significant in the opinion of the Principal Investigator.
  • Best corrected visual acuity worse than 20/80 Snellen in either eye.
  • Any abnormality preventing reliable applanation tonometry in either eye.
  • Intraocular conventional surgery or laser surgery in either eye less than 3 months prior to the Screening Visit.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the Investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • History of ocular herpes simplex.
  • Severe allergic rhinitis or bronchial hypersensitivity that would preclude the safe administration of a topical beta-blocker.
  • Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • Women who are pregnant, lactating, or of childbearing potential and not using a reliable means of birth control.
  • 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 1.0% + Timolol 0.5% ophthalmic suspension

Drug

Other names: AZARGA®

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Drug

Other names: COSOPT®

Primary outcomes

  1. Preferred Treatment

    Time frame: At the end of both periods, Day 15

    The participant completed a questionnaire on the Day 15 visit (ie, after administration of both study medications) consisting of a single preference question: "Thinking about the comfort of the two medications (1st and 2nd) that you took during this study, which medication do you prefer?" Preferred treatment is presented as a percentage.

Secondary outcomes

  1. Ocular Discomfort

    Time frame: Day 7 of each period

    Ocular discomfort was assessed by the participant 1 minute after instillation of the study medication. Ocular discomfort was rated on a 10-point scale (0=no discomfort, 9=substantial discomfort).

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Open-Angle Glaucoma or Ocular Hypertension

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 21, 2011
Registry last updated
Feb 10, 2014

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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