primary open-angle glaucoma ocular hypertension pigment dispersion glaucoma MedDRA version: 9.1 Level: LLT Classification code 10035015 Term: Pigmentary glaucoma MedDRA version: 9.1 Level: LLT Classification code 10030043 Term: Ocular hypertension MedDRA version: 9.1 Level: LLT Classifica
Conditions
Interventions
Trade Name: Azarga
Product Name: Azarga
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: BRINZOLAMIDE
Concentration unit: µ
Sponsors
Alcon Laboratories, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must be at least 21 years of age. Must be able to follow instructions and be willing and able to attend required study visits. Must have a clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye). 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 trial. In eyes not treated in the study the intraocular pressure should be able to be considered uncontrolled on prostaglandin monotherapy. Must have been treated with monotherapy for a minimum of four 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. At Visit 1, have an intraocular pressure of = 20 mm Hg in at least one eye and = 35 mm Hg in both eyes treated with prostaglandin monotherapy. Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye. 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
Exclusion criteria
Exclusion criteria: Presence of other primary or secondary glaucomas not listed in inclusion criterion 5.1.4. 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). Any abnormality preventing reliable applanation tonometry in qualifying eye(s). Presence of corneal dystrophies. Any opacity or patient uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. 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. Progressive retinal or optic nerve disease from any cause apart from glaucoma. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Any clinically significant, serious, or severe medical or psychiatric condition. A condition, which in the opinion of the investigator, would interfere with optimal participation in the study, or which would present a special risk to the patient. Participation in any other investigational study within 30 days prior to Visit 1. Known medical history of allergy or sensitivity to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the investigator. 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 systemic carbonic anhydrase inhibitors (e.g., methazolamide [Neptazane], acetazolamide [Diamox]) Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial. 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. Sinus bradycardia (< 55 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. History of myasthenia gravis. History of an allergy to sulfa. Unwillingness to accept the risk of iris, skin, or eyelash changes associated with prostaglandin therapy. A history of, or at risk for uveitis or cystoid macular edema (CME). History of ocular herpes simplex.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of adding to BTFC to prostaglandin monotherapy.;Secondary Objective: ;Primary end point(s): The mean intraocular pressure decrease at the final visit (Month 3, Visit 3) following the addition of BTFC at enrollment (Day 0, Visit 1) to previous prostaglandin monotherapy. | — |
Countries
Germany
Outcome results
None listed