Clinical trial NCT01263444: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: AZARGA®
Open angle glaucoma
Prostaglandin Therapy
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-12-20
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
timeFrame: Baseline, Week 12
measure: Mean Change From Baseline in IOP at Week 4
timeFrame: Baseline, Week 4
measure: Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
timeFrame: Week 12
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Severine Durier, Pharm. D
role: STUDY_DIRECTOR
References: