Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy
Primary Purpose
Glaucoma, Ocular Hypertension
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide 1% / timolol 0.5% Fixed Combination
Habitual prostaglandin monotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring AZARGA®, Open angle glaucoma, Prostaglandin Therapy
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of ocular hypertension, primary open angle (including pigment dispersion) glaucoma in both eyes.
- 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.
- Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1.
- At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy.
- Best corrected visual acuity of 1.0 LogMAR or better in each eye.
- In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
- Willing to sign an informed consent form.
- Able to follow instructions and willing and able to attend required study visits.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
- A history of, or at risk for uveitis or cystoid macular edema (CME).
- History of ocular herpes simplex.
- Corneal dystrophies in either eye.
- Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
- Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1.
- 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 apart from glaucoma.
- 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 Visit 1 or an anticipated change in the dosage during the course of the study.
- Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
- Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- History of severe allergic rhinitis.
- 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.
- Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide [Neptazane], acetazolamide [Diamox]).
- Severely impared renal function.
- History of an allergy to sulphonamides.
- Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
- Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control.
- Any clinically significant, serious, or severe medical condition.
- Participation in any other investigational study within 30 days prior to the screening/baseline visit.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Azarga
Arm Description
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.
Secondary Outcome Measures
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
Mean Change From Baseline in IOP at Week 4
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.
Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01263444
Brief Title
Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy
Official Title
Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (AZARGA®) to Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (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 evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.
Detailed Description
This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension
Keywords
AZARGA®, Open angle glaucoma, Prostaglandin Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azarga
Arm Type
Experimental
Arm Description
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1% / timolol 0.5% Fixed Combination
Other Intervention Name(s)
AZARGA®
Intervention Type
Drug
Intervention Name(s)
Habitual prostaglandin monotherapy
Other Intervention Name(s)
Latanoprost, Travoprost, Bimatoprost, Tafluprost
Intervention Description
Topical ocular therapy used daily as prescribed
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.
Time Frame
Baseline, Week 12
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
Time Frame
Baseline, Week 12
Title
Mean Change From Baseline in IOP at Week 4
Description
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. Only one eye (study eye) contributed to the mean.
Time Frame
Baseline, Week 4
Title
Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
Description
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of ocular hypertension, primary open angle (including pigment dispersion) glaucoma in both eyes.
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.
Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1.
At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy.
Best corrected visual acuity of 1.0 LogMAR or better in each eye.
In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
Willing to sign an informed consent form.
Able to follow instructions and willing and able to attend required study visits.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
A history of, or at risk for uveitis or cystoid macular edema (CME).
History of ocular herpes simplex.
Corneal dystrophies in either eye.
Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1.
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 apart from glaucoma.
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 Visit 1 or an anticipated change in the dosage during the course of the study.
Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
History of severe allergic rhinitis.
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.
Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide [Neptazane], acetazolamide [Diamox]).
Severely impared renal function.
History of an allergy to sulphonamides.
Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control.
Any clinically significant, serious, or severe medical condition.
Participation in any other investigational study within 30 days prior to the screening/baseline visit.
Other protocol-defined exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Severine Durier, Pharm. D
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
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Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy
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