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Patient Preference Comparison of AZARGA Versus COSOPT

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ClinicalTrials.gov Identifier: NCT01340014
Recruitment Status : Completed
First Posted : April 21, 2011
Results First Posted : December 13, 2013
Last Update Posted : February 10, 2014
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study Start Date : September 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
AZARGA/COSOPT
1 drop AZARGA instilled in each eye twice a day for 7 days, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension
Other Name: AZARGA®

Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution
Other Name: COSOPT®

COSOPT/AZARGA
1 drop COSOPT instilled in each eye twice a day for 7 days, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days. A 48-hour washout period separated the two treatment periods.
Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension
Other Name: AZARGA®

Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution
Other Name: COSOPT®




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340014


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Severine Durier, Pharm.D Alcon Global Medical Affairs, Europe

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01340014     History of Changes
Other Study ID Numbers: RDG-10-251
2010-024244-15 ( EudraCT Number )
First Posted: April 21, 2011    Key Record Dates
Results First Posted: December 13, 2013
Last Update Posted: February 10, 2014
Last Verified: January 2014

Keywords provided by Alcon Research:
Glaucoma
Intraocular pressure
Tonometry, ocular

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Dorzolamide
Ophthalmic Solutions
Brinzolamide
Pharmaceutical Solutions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors