Open angle glaucoma or ocular hypertension. MedDRA version: 18.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Preservative-free 0.2% Brimonidine/0.5% Timolol Eye Drops
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: BRIMONIDINE TARTRATE
CAS Number: 79570-1
Sponsors
OmniVision GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -male or female, of any race and =18 years of age; -diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension; -IOP =21 mmHg measured as the mean of two measurements in each eye and at least one hour apart; -on treatment for open-angle glaucoma with IOP-lowering drugs for at least 24 weeks (and the last 4 weeks with Combigan®), or treated with Combigan® for ocular hypertension for the last 4 weeks; -best-corrected visual acuity =20 of 100 corresponding to logMAR of 0.7 at both eyes; -in case of women; postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control measures; -expected by the investigator that IOP will remain controlled with the new 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 voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: Exclusion Criteria: -history of chronic or recurrent inflammatory eye disease, ocular trauma or infections; - any uncontrolled systemic disease; -narrow-angle/angle-closure glaucoma; -corneal abnormalities that will preclude accurate IOP reading with an applanation tonometer; -clinically significant or progressive retinal disease; -intraocular surgery within the past 6 months; -ocular laser surgery within the past 3 months; -best-corrected visual acuity worse than 0.7 logarithm of minimal angle of resolution (logMAR) score, extremely narrow or partially closed angle, cup/disk ratio >0.8; -ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine. -treatment with local or systemic corticosteroids; -receiving non-stable doses of any medication that could affect IOP within 30 days before the beginning of the clinical trial (e.g. clonidine); -contraindication to beta-adrenoceptor antagonist therapy included, but not limited to current reactive airway disease, bronchial asthma or a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with a 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 severe hepatic or renal impairment; -history of excessive consumption of alcohol or alcohol dependency during the last two years; -history of illicit drug abuse ( e.g. phencyclidine,benzodiazepines, cannabinoids, amphetamines, barbiturates, cocaine and opiates); -treatment with monoamine oxidase (MAO) inhibitor therapy (discontinued at least 14 days before); -treatment with adrenergic augmenting psychotropic drugs/antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin); -history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial; -pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control; -current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s); -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the clinical non-inferiority of a generic fixed combination of Brimonidine 0.2%/Timolol 0.5% eye drops solution in single dose container which is preservative-free, compared to the marketed preservative-containing Combigan® eye drops solution in patients with open angle glaucoma, or ocular hypertension, already on treatment with IOP-lowering drugs and low intraocular pressure (IOP=21 mmHg) by examining the average change of diurnal IOP from end of study to baseline.;Secondary Objective: •Secondary efficacy objectives are the average change of diurnal IOP measured between baseline and days 7 and 14 and the proportion of patients with measured IOP <21 mmHg at the end of the clinical trial. •Proportion of withdrawals for therapeutic failure (diurnal IOP =21 mmHg) at any time point during or at the end of week 4. ;Primary end point(s): Average diurnal IOP change from baseline to end of week 4.;Timepoint(s) of evaluation of this end point: At week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Average change of diurnal IOP from baseline to end of week 1. •Average change of diurnal IOP from baseline to end of week 2. •Proportion of patients with an IOP less than 21 mmHg at the end of week 4. •Proportion of withdrawals for therapeutic failure (diurnal IOP =21 mmHg) at any time point during or at the end of week 4. ;Timepoint(s) of evaluation of this end point: At weeks 1, 2 , baseline and 4 week | — |
Countries
Greece
Contacts
Public ContactCLINICAL TRIAL INFORMATION
BECRO
Outcome results
None listed