Patient Preference Comparison of AZARGA Versus COSOPT

NCT ID: NCT01340014

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-10-31

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension

Intervention Type: DRUG

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

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.

Group Type: OTHER

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension

Intervention Type: DRUG

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Interventions

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension

Intervention Type: DRUG

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

AZARGA®; COSOPT®

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Severine Durier, Pharm.D

Role: STUDY_DIRECTOR

Alcon Global Medical Affairs, Europe

Other Identifiers

2010-024244-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RDG-10-251

Identifier Type: -

Identifier Source: org_study_id