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Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil

Primary Purpose

Glaucoma

Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Brinzolamide/timolol maleate fixed combination
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • 18 years of age or older.
  • Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
  • Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
  • IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
  • Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
  • IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.
  • History of ocular herpes simplex.
  • Abnormality preventing reliable applanation tonometry.
  • Corneal dystrophies.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
  • Intraocular conventional surgery or laser surgery in study eye(s) less than three 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.
  • Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.
  • Pregnant or lactating.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

  • Contact Alcon Call Center for Trial Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AZARGA

Arm Description

Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks

Outcomes

Primary Outcome Measures

Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).
Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Secondary Outcome Measures

Full Information

First Posted
January 18, 2012
Last Updated
August 15, 2013
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01514734
Brief Title
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil
Official Title
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment rate
Study Start Date
March 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle 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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZARGA
Arm Type
Experimental
Arm Description
Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Brinzolamide/timolol maleate fixed combination
Other Intervention Name(s)
AZARGA®
Intervention Description
Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).
Description
Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older. Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye). Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit. IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period. Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye. IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Presence of other primary or secondary glaucoma not listed in inclusion criteria #2. History of ocular herpes simplex. Abnormality preventing reliable applanation tonometry. Corneal dystrophies. Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. Intraocular conventional surgery or laser surgery in study eye(s) less than three 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. Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study. Pregnant or lactating. Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Hubatsch, M.Sc.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
São Paulo
ZIP/Postal Code
11045-140
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil

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