Non-inferiority study between two formulations Brimonidine 0.2%/Timolol 0.5% eye drops solution

Prior treatment

• Current use of topical, ocular, nonsteroidal anti-inflammatory drugs
• Ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine
• Treatment with local or systemic corticosteroids;
• Treatment with monoamine oxidase (MAO) inhibitor therapy or discontinuation of the treatment less than 15 days before randomization;
• Treatment with adrenergic augmenting psychotropic drugs/antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin);
• Any change in any systemic medication that affects IOP within the last 30 days (e.g. clonidine, etc.);
• Treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide);
• Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s);
• Intraocular surgery within the past 3 months;
• Ocular laser surgery within the past 1 months;

Other illness

• Ηistory 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;
• History of reactive airway disease including bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease;
• History of sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker, overt cardiac failure, cardiogenic shock
• History of severe or unstable and uncontrolled cardiovascular disease;
• History of depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
• History of anterior chamber lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema
• A history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial
• Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment);

Other

• 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
• Who are legally detained in an official institute
• Narrow-angle/angle-closure glaucoma;
• Corneal abnormalities that will preclude accurate IOP reading with an aplanation tonometer
• Best-corrected visual acuity < 20 of 100 (Snellen), corresponding to worse than 0.7 logarithm of minimal angle of resolution (logMAR) score;
• Cup/disk ratio >0.8;

• Male or female, of any race and ≥18 years of age.
• Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits;
• Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
• Diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension
• Average IOP ≥ 22 mmHg and ≤ 35 mmHg measured at 08:00, 12:00 and 16:00 hours pre-treatment in at least one eye at day 0.
• 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 of ≤0.7.
• No new systemic medication that may alter IOP in the previous 30 days (e.g. beta-blockers, Ca-channel-blockers, ACE-inhibitors, prostaglandins, etc.), or expected to continue the current treatment with these medicinal products on stable regimen for 30 days prior to the study and during the study.
• Patients with controlled arterial blood pressure according to the investigator’s opinion.
• 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 with the new treatment without optic nerve damage or progression of visual field loss;