This study will evaluate and confirm that the efficacy and tolerability of a New Preservative-free Formulation of Brimonidine 2 mg/ml Eye Drops is not worse compared to the marketed preservative-containing formulation Alphagan™ Eye Drops in Patients with Open Angle Glaucoma or Ocular Hypertensio
- Conditions
- Open angle glaucoma or ocular hypertension.MedDRA version: 14.1Level: PTClassification code 10030043Term: Ocular hypertensionSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-003083-31-GR
- Lead Sponsor
- OmniVision GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
-Patients being male or female, of any race and =18 years of age; diagnosed of unilateral or bilateral open angle glaucoma or ocular hypertension;
-on treatment with Alphagan for at least 4 weeks;
-on treatment with an IOP =21 mmHg measured as the mean of both eyes at two measurements at least one hour apart;
-best-corrected visual acuity =20 of 100 corresponding to logMAR of 0.7 in both eyes; in case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or on use of effective birth control measures;
-expected by the investigator that IOP would remain controlled under the investigational treatments 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 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 85
-Patients with a history of chronic or recurrent inflammatory eye disease, ocular trauma or infections;
-narrow-angle/angle-closure glaucoma;
-corneal abnormalities that will preclude accurate IOP reading with an aplanation 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;
-history of bronchial asthma, or severe chronic obstructive pulmonary disease; reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease.
treatment with local or systemic corticosteroids;
-inability to discontinue the use of glucocorticoid medications;
-not receiving stable doses of any medication that could affect IOP for 30 days before the beginning of the clinical trial (e.g. clonidine);
-monoamine oxidase (MAO) inhibitor therapy and patients on antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin);
-a history of allergic hypersensitivity or poor tolerance to any component of the eye drop solution used in this clinical trial or a contraindication of ß-adrenergic receptor antagonists due to systemic disease;
severe or unstable and uncontrolled cardiovascular disease;
depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans;
-hepatic or renal impairment;
-sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock;
-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.
Patients requiring bilateral IOP-reducing therapy are treated in both eyes, but only the eye(s) that fulfil(s) all of the inclusion criteria and none of the exclusion criteria are designated as clinical trial eye(s). An eye not meeting all inclusion criteria but having none of the exclusion criteria may be treated with the clinical trial drug at the discretion of the investigator
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the clinical trial to confirm the clinical non-inferiority of the preservative-free Brimonidine containing eye drops compared with the marketed preservative-containing Alphagan™ eye drops by the average decrease of diurnal IOP measured between the first and last visit. ;Secondary Objective: NOT APPLICABLE;Primary end point(s): Average diurnal IOP decrease from baseline to last visit at week 4.;Timepoint(s) of evaluation of this end point: At week 4
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Average decrease of diurnal IOP measured between baseline and week 1. <br>-Average decrease of diurnal IOP measured between baseline and week 2. <br>-Proportion of patients with measured IOP <21 mmHg at the end of the study. <br>;Timepoint(s) of evaluation of this end point: At week 4