Comparison of the Efficacy of AZARGA® Versus COSOPT® in P... | NCT01111890

Studies
Comparison of the Efficacy of AZARGA® Versus COSOPT® in Patients With Open-Angled Glaucoma or Ocular Hypertension

NCT01111890

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Jul 29, 2015Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Glaucoma
Ocular Hypertension

Interventions

Azarga (brinzolamide 1% / timolol 0.5%)
Cosopt (dorzolamide 2% / timolol 0.5%)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

Apr 26, 2010

First Submission Date that Met QC Criteria

Apr 26, 2010

First Posted Date

Apr 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2015

Last Update Posted Date

Jul 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Azarga	Experimental	Azarga (brinzolamide 1% / timolol 0.5%)	Drug: Azarga (brinzolamide 1% / timolol 0.5%)
Cosopt	Active Comparator	Cosopt (dorzolamide 2% / timolol 0.5%)	Drug: Cosopt (dorzolamide 2% / timolol 0.5%)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Azarga (brinzolamide 1% / timolol 0.5%)	Drug	Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks	Azarga

Measure	Description	Time Frame
Mean change in Intraocular Pressure (IOP) following 12 weeks of twice daily dosing		12 weeks

Measure	Description	Time Frame
Percentage of subjects with IOP ≤ 18 millimeters mercury (mmHg)		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be at least 18 years of age.
Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye).
Must have IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
Must be willing to discontinue the use of all other ocular hypotensive agents prior to receiving the assigned study drug at Visit 1, throughout the study period.
Must have an IOP of between 19 to 35 mmHg in at least one eye (which would be the study eye).
For the eyes not included in the study, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on the study medicine alone.

Exclusion Criteria:

Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
Any abnormality preventing reliable applanation tonometry in study eye(s).
Risk of visual field or visual acuity worsening due to participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Day 1 Visit or an anticipated change in the dosage during the course of the study.
A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
Participation in any other investigational study within 30 days prior to Visit 1.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
C571752	Azarga
C111827	brinzolamide
C479140	dorzolamide-timolol combination
C062765	dorzolamide

ID	Term
D005901	Glaucoma
D009798	Ocular Hypertension