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

Trial details

Who runs it

Becro (Cyprus) Limited

Trial code

EU 2023-507285-24-00

Record updated

2024. március 22.

Original description

To confirm the clinical non-inferiority of a fixed-Combination Generic Formulation of Brimonidine0.2%/Timolol 0.5% eye drops, solution in single-dose container with the marketed preservative-containing Combigan® eye drops, solution in patients with open angle glaucoma, or ocular hypertension (IOP≥22 mmHg) by examining the change of IOP at 08:00 from end of study to baselineRead full original descriptionShow less

Non-inferiority Clinical Trial for Comparing the Efficacy and Tolerability of a new fixed-Combination Generic Formulation of Brimonidine 0.2%/Timolol 0.5% eye drops, solution in single-dose containers vs Combigan® eye drops, solution in Patients with Open Angle Glaucoma or Ocular Hypertension

To confirm the clinical non-inferiority of a fixed-Combination Generic Formulation of Brimonidine0.2%/Timolol 0.5% eye drops, solution in single-dose container with the marketed preservative-containing Combigan® eye drops, solution in patients with open angle glaucoma, or ocular hypertension (IOP≥22 mmHg) by examining the change of IOP at 08:00 from end of study to baseline

Inclusion: 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.

Exclusion: 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; 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); 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.

EU CTIS 2023-507285-24-00