Patient Preference Comparison of AZARGA Versus COSOPT

NCT01340014 | Completed Phase 4 Results

• 2 other identifiers: RDG-10-2512010-024244-15
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Glaucoma; Intraocular pressure; Tonometry, ocular

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of both periods, Day 15

Secondary Outcomes (1)

• Ocular Discomfort

  Day 7 of each period

Study Arms (2)

AZARGA/COSOPT

OTHER

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.

Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

COSOPT/AZARGA

OTHER

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.

Drug: Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension; Drug: Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution

Interventions

Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension DRUG

Also known as: AZARGA®

AZARGA/COSOPT; COSOPT/AZARGA

Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution DRUG

Also known as: COSOPT®

AZARGA/COSOPT; COSOPT/AZARGA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

brinzolamide; Timolol; Azarga; dorzolamide; Ophthalmic Solutions; dorzolamide-timolol combination

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Doug Hubatsch, Global Brand Leader, Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Severine Durier, Pharm.D

  Alcon Global Medical Affairs, Europe

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: April 20, 2011
• First Posted: April 21, 2011
• Study Start: September 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: February 10, 2014
• Results First Posted: December 13, 2013

Record last verified: 2014-01