A prospective, phase III, multicenter, randomized, investigator-masked, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety and of a generic fixed combination of Brinzolamide 10mg/ml / Timolol 5 mg/ml eye drops suspension versus Azarga®/ALCON 10mg/ml – 5mg/ml eye drops suspension in subjects with open angle glaucoma or ocular hypertension.
- Conditions
- open-angle glaucoma or ocular hypertensionMedDRA version: 20.0Level: PTClassification code 10030348Term: Open angle glaucomaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2019-000921-39-GR
- Lead Sponsor
- PHARMATHEN SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 216
1.Male or female subjects, of any race or ethnicity, aged = 18 years
•In case of women, postmenopausal (>12 months without menstrual bleeding), surgically sterilized, or using effective birth control measures.
2.Subjects diagnosed with bilateral or unilateral open angle glaucoma or ocular hypertension in at least one eye
•Subjects may be naïve to antiglaucoma medications or treated for their elevated IOP, which however is insufficiently controlled either on monotherapy or on two IOP-lowering medications.
3.Mean IOP measurements for = 1 eye (the same eye) must be 24 - 36 mm Hg at 08:00 a.m. and 21 - 36 mm Hg at 10:00 a.m. during the baseline visit (following the required washout period for non-naïve patients)
4.Mean IOP = 36 mm Hg in both eyes at all time points of the baseline visit.
5.Without treatment for open angle glaucoma with IOP-lowering drugs for at least as many days as appropriate by the washout schedule. For subjects not taking any IOP-lowering medications, this time-period should be 3 ± 1 days.
6.Best corrected visual acuity of = 20/100 (Snellen chart) corresponding to logMAR score of 0.7.
7.Subjects able to understand the requirements of the clinical trial and to agree to return for the follow-up visits.
8.Subjects 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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 108
Related to the eye:
1.History of chronic, recurrent or current severe inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis) in either eye.
2. Schaffer angle grade < 2 in either eye (range, 0 [complete or partial closure] to 3 [ wide open angle, > 20o]), as measured by gonioscopy.
3.Cup-to-disc ratio > 0.80 (horizontal or vertical measurement) in either eye.
4.Severe central visual field loss (i.e. sensitivity = 10 dB in = 2 of the 4 visual field test points closer to the point of fixation) in either eye.
5.Best corrected visual acuity = 20/100 (Snellen chart) corresponding to worse than 0.7 logarithm of minimal angle or resolution (logMAR) score.
6.Central corneal thickness > 620 µm, as measured by pachymetry, in either eye.
7.Any corneal abnormalities or any abnormality that will preclude accurate and reliable IOP reading with an applanation tonometer.
8.Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination.
9.Clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) in either eye
10.History of anterior chamber intra-ocular lens, torn posterior lens capsule, aphakia or any known risk factor for cystoid macular edema.
11.Ocular pathology in either eye (including severe dry eye) that may prohibit the administration of an a-adrenergic agonist and/or a topical carbonic anhydrase inhibitors (CAIs)
12.Inability to safely discontinue use of or go without IOP-lowering ocular medications as per the washout schedule.
13.Intraocular surgery = 6 months before the study
14.Ocular laser surgery = 3 months before the study
Related to systemic health
15.<30-day stable dosing regimen before the screening visit of any long-term systemic medication or substance that may affect IOP (e.g. ß-blockers, calcium channel blockers, angiotensin converting enzyme ([ACE] inhibitors, prostaglandins, clonidine)
16.Use of high-dose (>1 g daily) salicylate therapy, = 4 weeks before the baseline visit.
17.Therapy with another investigational agent = 30 days before the screening visit.
18.Concurrent use of a MAO inhibitor, any additional systemic or topical ocular hypotensive medications or glucocorticoid (topical or systemic) medications.
19.Current use of topical, ocular non-steroidal anti-inflammatory medications.
20.Treatment with oral carbonic anhydrase inhibitors (e.g. acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
21.Current or anticipated treatment with psychotropic medications that augment adrenergic response (e.g. dopamine, amitriptyline).
22.Active or prior, severe, unstable, or uncontrolled cardiovascular (sinus bradycardia, sick sinus syndrome, sinoatrial block, second or third degree atrioventricular block not controlled with pacemaker, overt cardiac failure, cardiogenic shock), reactive airway disease (bronchial asthma or a history of bronchial asthma, severe COPD) or renal disease (severe renal insufficiency [creatinine clearance < 30 ml/min) or hyperchloremic acidosis) that would prevent safe administration of topical a-adrenergic agonists or carbonic anhydrase inhibitors, according to the Investigator’s judgement.
23.Hypersensitivity to timolol, topical or oral CAIs (brinzolamide), sulfonamide derivatives or any components of the study drug medications
24.Pregnant/nursing, planning to become pregnant or not using adequate birth control women of childbearing potential, during the study
25.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method