NCT01471158

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 ocular hypertension.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2011

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2011

Enrollment Period

8 months

First QC Date

November 10, 2011

Last Update Submit

November 18, 2016

Conditions

Glaucoma

Keywords

Primary open-angle glaucomaocular hypertensionpigment dispersion glaucoma

Outcome Measures

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.

    One minute after instillation

Study Arms (2)

Azarga/Cosopt

ACTIVE COMPARATOR

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)

Cosopt/Azarga

ACTIVE COMPARATOR

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

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)DRUG

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®
Azarga/CosoptCosopt/Azarga
Dorzolamide/timolol Maleate Fixed Combination (COSOPT)DRUG

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®
Azarga/CosoptCosopt/Azarga

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Oftalmológico

Buenos Aires, 1425, Argentina

Location

Related Publications (1)

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

    RESULT

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleOcular Hypertension

Interventions

brinzolamideAzargadorzolamidedorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Abayomi Ogundele, PharmD

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2011

First Posted

November 15, 2011

Study Start

September 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

November 21, 2016

Record last verified: 2011-11

Locations

AR(1)