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

Trial details

Who runs it

OmniVision GmbH

Trial code

EU 2023-506494-35-00

Record updated

2025. január 28.

Original description

To confirm the clinical non-inferiority of a new generic fixed combination of Brinzolamide 10mg/ml + Timolol 5mg/ml eye drops compared to the reference product Azarga® 10mg/ml + 5mg/ml eye drops, in patients with elevated intraocular pressure (open angle glaucoma or ocular hypertension) by examining the average change of diurnal intraocular pressure (IOP) from end of study to baseline and comparing between the two study arms.Read full original descriptionShow less

A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-reference, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Combination of Brinzolamide 10mg/ml + Timolol 5mg/ml Eye Drops versus Azarga® 10mg/ml + 5mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension

To confirm the clinical non-inferiority of a new generic fixed combination of Brinzolamide 10mg/ml + Timolol 5mg/ml eye drops compared to the reference product Azarga® 10mg/ml + 5mg/ml eye drops, in patients with elevated intraocular pressure (open angle glaucoma or ocular hypertension) by examining the average change of diurnal intraocular pressure (IOP) from end of study to baseline and comparing between the two study arms.

Inclusion: 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.

Exclusion: 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; 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; 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.

EU CTIS 2023-506494-35-00