Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension
• Interventions: Drug: Brinzolamide 1% / timolol 0.5% Fixed Combination; Drug: Habitual prostaglandin monotherapy

• Registration Number: NCT01263444
• Lead Sponsor: Alcon Research

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2010-12-17
• Study First Submitted QC: 2010-12-17
• Study First Posted: 2010-12-20
• Study Start: 2011-03
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Results First Submitted: 2014-04-23
• Results First Submitted QC: 2014-04-23
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-18
• Results First Posted: 2014-05-19
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Azarga	Habitual prostaglandin monotherapy	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.
Azarga	Brinzolamide 1% / timolol 0.5% Fixed Combination	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.

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12	Baseline, 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

Name	Time	Method
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12	Baseline, 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	Baseline, 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)	Week 12	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.