open-angle glaucoma or ocular hypertension MedDRA version: 20.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Brinzolamide – Timolol ophthalmic suspension
Pharmaceutical Form: Eye drops, suspension
INN or Proposed INN: BRINZOLAMIDE
CAS Number: 138890-62-7
Other descriptive name: BRINZOLAMIDE
Con
Sponsors
PHARMATHEN SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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. 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. U
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to confirm the non-inferiority of the generic fixed combination of Brinzolamide 10mg/ml / Timolol 5mg/ml eye drops suspension (test product, PHARMATHEN Pharmaceuticals) in lowering the intra-ocular pressure (IOP) when compared to Brinzolamide 10mg/ml / Timolol 5mg/ml eye drops suspension marketed product Azarga® (reference product, ALCON) in subjects with open-angle glaucoma or ocular hypertension, by examining the mean diurnal IOP change from baseline to week 12 visit. The mean diurnal IOP change will be calculated as the average of the 08:00 a.m. and 10:00 a.m. time point measurements.;Secondary Objective: • To compare the efficacy of the two products (test and reference) in terms of IOP change. • To compare their tolerability.;Primary end point(s): The primary efficacy endpoint will be the difference between test and reference product of the mean diurnal IOP change from baseline to week 12 visit. The mean diurnal IOP change will be calculated as the average of the 08:00 a.m. and 10:00 a.m. time point measurements at each visit (baseline, week 12). ;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The assessment of any AE occurrences and general safety at the test and the reference products.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Countries
Cyprus, Greece
Contacts
Public ContactClinical Affairs
PHARMATHEN SA
Outcome results
None listed