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

Prior treatment

• use at any time prior to baseline of intraocular corticosteroid implant
• use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
• use within one month prior to baseline of: 1) systemic corticosteroid, 2) monoamine oxidase (MAO) inhibitor therapy, 3) any antidepressant which affects noradrenergic transmission (e.g., tricylic antidepressants, mianserin) or 4) adrenergic-augmenting psychotropic drug (e.g., desipramine, amitriptyline)
• use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
• underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction
• current participation or not yet completed period of at least 30 days since ending of another investigational device or drug trial(s)
• treatment with local or systemic corticosteroids in non-stable doses in the last 30 days
• intraocular surgery within the past 3 months
• ocular laser surgery within the past 1 month
• planned ocular surgery of any kind during study participation
• treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
• ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine
• current use of topical, ocular, nonsteroidal anti-inflammatory drugs
• 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.)

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 other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a beta-blocker
• a history of depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
• any uncontrolled systemic disease
• current reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
• severe acute 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
• a history of, or current severe hepatic or renal impairment
• known hypersensitivity to beta-blockers
• a history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial

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
• narrow-angle/angle-closure glaucoma
• 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
• 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
• willing to provide voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed
• diagnosed of unilateral or bilateral open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension
• average IOP ≥ 22 mm Hg and ≤ 34 mm Hg measured at 08:00 am, 12:00 am and 04:00 pm pre-treatment at baseline in at least one eye
• without treatment for open-angle glaucoma with IOP-lowering drugs, for at least 4 weeks
• best-corrected visual acuity ≥20 of 100 (Snellen) corresponding to logMAR ≤ 0.7 in the study eye
• 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
• patients with controlled arterial blood pressure according to the investigator’s opinion
• able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits