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Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 4

Locations

Argentina

Study Type

Interventional

Intervention

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Primary open-angle glaucoma, ocular hypertension, pigment dispersion glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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.

Sites / Locations

Centro Oftalmológico

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Azarga/Cosopt

Cosopt/Azarga

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01471158

First Posted

November 10, 2011

Last Updated

November 18, 2016

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01471158

Brief Title

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

Official Title

Patient Preference Comparison of AZARGA Versus COSOPT After Single Doses in Patients With Open-Angled Glaucoma or Ocular Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

Primary open-angle glaucoma, ocular hypertension, pigment dispersion glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Azarga/Cosopt

Arm Type

Active Comparator

Arm Description

Arm Title

Cosopt/Azarga

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Other Intervention Name(s)

AZARGA®

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Dorzolamide/timolol Maleate Fixed Combination (COSOPT)

Other Intervention Name(s)

COSOPT®

Intervention Description

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.

Primary Outcome Measure Information:

Title

Discomfort

Description

Time Frame

One minute after instillation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abayomi Ogundele, PharmD

Organizational Affiliation

Alcon Research

Official's Role

Study Director

Facility Information:

Facility Name

Centro Oftalmológico

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

12. IPD Sharing Statement

Citations:

Citation

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

Results Reference

result

Learn more about this trial

Patient Preference Comparison of AZARGA Versus COSOPT in Patients With Glaucoma

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