A Study for Comparing a Generic Combination of Brinzolamide and Timolol Eye Drops versus Azarga® Eye Drops in the Treatment of Patients with Glaucoma

Prior treatment

• treatment with local or systemic corticosteroids in non-stable doses in the last 30 days
• treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
• any change in any systemic medication that could affect IOP within the last 30 days before the beginning of and during the study (e.g., clonidine, β-blockers etc.)
• current participation or not yet completed period of at least 30 days since ending of another investigational device or drug trial(s)
• intraocular surgery within the past 3 months
• ocular laser surgery within the past 1 month
• planned ocular surgery of any kind during study participation

Other illness

• history of chronic or recurrent inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis), ocular trauma within the past 6 months or ocular inflammation within the past 3 months or infections
• a history of, or current severe hepatic or renal impairment
• a history of, or current hyperchloraemic acidosis
• known hypersensitivity to sulphonamides
• known hypersensitivity to beta-blockers
• history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial
• a history of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a topical carbonic anhydrase inhibitor (CAI) or beta-blocker
• any uncontrolled systemic disease
• current reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
• severe allergic rhinitis
• sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
• overt cardiac failure, cardiogenic shock
• severe illness or other condition that would make the patient, in the opinion of the Investigator, unsuitable for the study
• clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) in either eye

Other

• severe central visual field loss (i.e., sensitivity ≤10 decibel [dB] in at least 2 of the 4 visual field test points closest to the point of fixation) in either eye
• pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control
• unwillingness or inability to comply with the clinical trial procedures
• unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
• who are legally incapacitated
• narrow-angle/angle-closure glaucoma
• who are legally detained in an official institute
• compromised cornea or corneal abnormalities that will preclude accurate IOP-reading with an applanation tonometer
• extremely narrow or partially closed angle, cup/disk ratio >0.8

• male or female, of any race and ≥18 years of age
• diagnosed of unilateral or bilateral open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension; either on treatment or treatment naïve
• able to safely discontinue use of all ocular hypotensive medication(s) and undergo appropriate washout period
• best-corrected visual acuity ≥20 of 100 corresponding to logMAR ≤ 0.7 in both eyes
• females who participate in the study are either unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control throughout the study; reliable contraception methods are considered the following: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal; progestogen-only hormonal contraception associated with inhibition of ovulation oral, implantable or injectable; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence
• expected by the investigator that IOP will remain controlled under treatment without optic nerve damage or progression of visual field loss
• able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits
• willing to provide voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed