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Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

Primary Purpose

Glaucoma

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, IOP, AZARGA

Eligibility Criteria

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

Inclusion Criteria:

Sign Informed Consent.
21 years of age or older.
Able to follow instructions and willing to attend required study visits.
Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
Intra-ocular pressure (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 trial.
Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of other primary or secondary glaucomas not listed in inclusion criterion.
Presence of corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
Women of childbearing potential not using reliable means of birth control.
Women who are pregnant or lactating.
Participation in any other investigational study within 30 days prior to Visit 1.
Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
Severe allergic rhinitis
History of ocular herpes simplex.
Other protocol-defined exclusion criteria may apply.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brinzolamide/Timolol Maleate Fixed Combination

Arm Description

Outcomes

Primary Outcome Measures

The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline

Secondary Outcome Measures

Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success

Full Information

NCT ID

NCT00966576

First Posted

August 26, 2009

Last Updated

November 18, 2016

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT00966576

Brief Title

Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

Official Title

The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (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 is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.

6. Conditions and Keywords

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

Glaucoma

Keywords

Glaucoma, IOP, AZARGA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Brinzolamide/Timolol Maleate Fixed Combination

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Other Intervention Name(s)

AZARGA

Intervention Description

1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks

Primary Outcome Measure Information:

Title

The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success

Time Frame

Week 4 and Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Sign Informed Consent. 21 years of age or older. Able to follow instructions and willing to attend required study visits. Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye). Intra-ocular pressure (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 trial. Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Presence of other primary or secondary glaucomas not listed in inclusion criterion. Presence of corneal dystrophies. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1. Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Participation in any other investigational study within 30 days prior to Visit 1. Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial. Severe allergic rhinitis History of ocular herpes simplex. Other protocol-defined exclusion criteria may apply.

Facility Information:

City

Mainz

ZIP/Postal Code

55101

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

22205835

Citation

Lorenz K, Rosbach K, Matt A, Pfeiffer N. Addition of a fixed combination of brinzolamide 1%/timolol 0.5% to prostaglandin monotherapy in patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2011;5:1745-50. doi: 10.2147/OPTH.S25987. Epub 2011 Dec 9.

Results Reference

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Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

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