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CompletedNCT01471158Updated Nov 21, 2016

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

A Phase 4 interventional study of Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) and Dorzolamide/timolol Maleate Fixed Combination (COSOPT) in Glaucoma, sponsored by Alcon Research. Completed at 1 site in Argentina. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-21.

Sponsored by Alcon Research · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 ocular hypertension.

02

Conditions studied

  • Glaucoma

Keywords

  • Primary open-angle glaucoma
  • ocular hypertension
  • pigment dispersion glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 120 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • 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) · Drug: Dorzolamide/timolol Maleate Fixed Combination (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) · Drug: Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

Interventions

  • DrugBrinzolamide/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.

    Also known as: AZARGA®

  • DrugDorzolamide/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.

    Also known as: COSOPT®

06

What researchers measure

Primary outcomes

  1. Discomfort

    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.

    Time frame: One minute after instillation

07

Study locations

1 site
  • Centro Oftalmológico
    Buenos Aires, 1425, Argentina
08

References and documents

Publications

  • https://www.dovepress.com/preference-for-a-fixed-combination-of-brinzolamidetimolol-versus-dorzo-peer-reviewed-article-OPTH
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01471158
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Nov 15, 2011
Start date
Sep 2010
Primary completion
May 2011
Completion
May 2011
Last update
Nov 21, 2016

Study contacts

Abayomi Ogundele, PharmD
study director · Alcon Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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