The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma
patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin
monotherapy.
Inclusion Criteria:
- An EC-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.
- 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 lOP 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 prostaglandin 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 greater than or equal to 20 mm Hg in at
least one eye and greater than or equal to 35mm 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.
Exclusion Criteria:
- Presence of other primary or secondary glaucomas not listed in inclusion criterion.
- 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 lOP (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.
- Severe allergic rhinitis
- Hypersensitivity to beta-blockers other than timolol
- Severely impaired renal function
- Hyperchloremic acidosis
- 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.
Alcon Call Center, Phone: 1-888-451-3937, Email: medical.information@alconlabs.com
