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Patient Preference Comparison of AZARGA Versus COSOPT

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Glaucoma, Intraocular pressure, Tonometry, ocular

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

AZARGA/COSOPT

COSOPT/AZARGA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Preferred Treatment

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

Ocular Discomfort

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).

Full Information

NCT ID

NCT01340014

First Posted

April 20, 2011

Last Updated

January 13, 2014

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01340014

Brief Title

Patient Preference Comparison of AZARGA Versus COSOPT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

September 2011 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (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 was to assess patient preference regarding ocular comfort of AZARGA® compared to COSOPT® after one week instillation of each study medication.

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.

6. Conditions and Keywords

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

Open-Angle Glaucoma, Ocular Hypertension

Keywords

Glaucoma, Intraocular pressure, Tonometry, ocular

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AZARGA/COSOPT

Arm Type

Other

Arm Description

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.

Arm Title

COSOPT/AZARGA

Arm Type

Other

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension

Other Intervention Name(s)

AZARGA®

Intervention Type

Drug

Intervention Name(s)

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Other Intervention Name(s)

COSOPT®

Primary Outcome Measure Information:

Title

Preferred Treatment

Description

Time Frame

At the end of both periods, Day 15

Secondary Outcome Measure Information:

Title

Ocular Discomfort

Description

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).

Time Frame

Day 7 of each period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Severine Durier, Pharm.D

Organizational Affiliation

Alcon Global Medical Affairs, Europe

Official's Role

Study Director

12. IPD Sharing Statement

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Patient Preference Comparison of AZARGA Versus COSOPT

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