Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) in Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy
- Conditions
- ocular hypertension or glaucomaMedDRA version: 14.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10030856Term: Open-angle glaucomaSystem Organ Class: 10015919 - Eye disorders
- Registration Number
- EUCTR2010-022948-21-AT
- Lead Sponsor
- Alcon Research, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
1.Must be at least 18 years of age.
2.Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
3.Must have 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.
4.Must have been treated with, and in the Investigator’s judgment have demonstrated an adequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Also, the last dose of their prostaglandin must have been instilled correctly so the patient is within the dosing cycle at Visit 1.
5.At Visit 1, must have an intraocular pressure of = 20 mm Hg in at least one eye and = 35 mm Hg in both eyes treated with prostaglandin monotherapy.
6.Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
7.In any eye not qualifying as a study eye, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
8.Patients who wear contact lenses must be able to remove them for study medication administration and wait at least 15 minutes after administration before reinserting them.
9.An Ethics Committee reviewed and approved (for use in this study) informed consent form must be read, signed, and dated by the participating patient, as well as signed and dated by the individual (Principal Investigator or other site personnel) obtaining the informed consent, before conducting the Screening Visit and prior to initiation of study procedures.
10.Must be able to follow instructions and be willing and able to attend required study visits.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Known medical history of allergy, hypersensitivity or poor tolerance to any components of the preparations to be used in this study that is deemed clinically significant in the opinion of the Investigator.
2.Presence of other primary or secondary glaucoma not listed in inclusion criterion #2.
3.Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable).
4.A history of, or at risk for uveitis or cystoid macular edema (CME).
5.History of ocular herpes simplex.
6.Any abnormality preventing reliable applanation tonometry in study eye(s).
7.Corneal dystrophies in either eye.
8.Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
9.Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival hyperemia is allowed.
10.Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening/Baseline Visit.
11.Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator’s best judgment.
12.Progressive retinal or optic nerve disease from any cause apart from glaucoma.
13.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 Screening/Baseline Visit or an anticipated change in the dosage during the course of the study.
14.Use of corticosteroids (oral, topical ocular or nasal) within 30 days of the Screening/Baseline Visit and during the course of the study.
15.Use of any systemic carbonic anhydrase inhibitors (e.g., methazolamide [Neptazane], acetazolamide [Diamox])
16.Severely impaired renal function
17.Hyperchloremic acidosis
18.History of myasthenia gravis.
19.History of an allergy to sulphonamides
20.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.
21.Sinus bradycardia (< 50 beats per minute), second- or third-degree atrioventricular block, sino-atrial block, overt cardiac failure, or cardiogenic shock that would preclude the safe administration of a topical beta-blocker.
22.Women of childbearing potential not using a reliable method of birth control
23.Women who are pregnant or lactating
24.Any clinically significant, serious, or severe medical condition.
25.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 patient.
26.Participation in any other investigational study within 30 days prior to Visit 1.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method