Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction MedDRA version: 19.0 Level: HLGT Classification code 10018307 Term: Glaucoma and ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 19.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: Brinzolamide 10mg/ml + Timolol 5mg/ml
Product Code: Brinzolamide 10mg/ml + Timolol 5mg/ml
Pharmaceutical Form: Ear/eye drops, suspension
INN or Proposed INN: Brinzolamide
CAS Number: 138
Sponsors
AZAD Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Elevated IOP / primary open angle glaucoma (irideocorneal angle > 30°) in at least one eye: IOP pre-treatment (measured at approx. 8 am, 10 am and 4 pm) must be equal or higher than 22 mmHg, and equal or lower to 35 mmHg (untreated, i.e. naïve or after washout). 2. Not on any ophthalmic pressure-lowering medication, or in the condition not to suffer an untoward effects by withdrawal from current pressure-lowering medications for the washout period(s). 3. No ocular trauma, surgery, inflammation or infection, no corneal foreign body in the previous 3 months. 4. No clinically significant or progressive retinal disease as determined by dilated peripheral retinal examination done at screening. 5. No concomitant use of any topical ophthalmic medication other than artificial tears. 6. No ocular glucocorticoids in the previous 3 months. 7. Only for contact lens wearers: contact lenses must be removed prior to each drug application and be kept out for a minimum of 15 minutes after drug application. In addition contact lenses must remain out for a minimum of 20 minutes when ocular comfort assessments are required. 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Visual acuity of less than distance Snellen 20/100 corresponding to decimal 0.20 or 0.70 logMAR in either eye. 2. Evidence of acute ocular infection, corneal foreign body, or ocular inflammation. 3. Previous significant ocular trauma, laser or incisional surgery within 3 months of the screening visit. 4. Any corneal abnormalities preventing reliable applanation tonometry. 5. Patients with risk of angle closure or evidence of acute, intermittent or chronic angle closure. 6. Types of glaucoma other than POAG with glaucomatous optic disc morphology or glaucoma visual field defect such as pigmentary or pseudo-exfoliative glaucoma. 7. Pupil with inadequate ability to dilate sufficiently for peripheral retinal examination. 8. History or evidence of severe inflammatory eye disease (i.e. uveitis, retinitis, scleritis) in one or both eyes. 9. Traumatic cataract surgery with an open posterior capsule or any patient with an anterior chamber intraocular lens implant or aphakia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of the generic Brinzolamide 10 mg/ml + Timolol 5 mg/ml eye drops suspension AZAD Pharma AG (test product) in lowering intra-ocular pressure (IOP) when compared to Brinzolamide 10 mg/ml + Timolol 5mg/ml eye drops suspension product Azarga® (reference product, Alcon Ltd).;Secondary Objective: 1. To compare the tolerance of the test and reference products using a ocular comfort level score. 2. To compare the levels of conjunctival hyperaemia induced by test product and reference product. 3. To evaluate the general safety of the test product compared to the reference product.;Primary end point(s): Primary endpoint is non-inferiority of test product when compared with reference product, with respect to the differences in the mean diurnal IOP measured at approximately 8 am, 10 am and 4 pm in the study eye between Day 1 (baseline, before treatment) and Day 22 (under treatment).;Timepoint(s) of evaluation of this end point: Diurnal IOP measured at approximately 8 am, 10 am and 4 pm in the study eye between Day 1 (baseline, before treatment) and Day 22 (under treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Ocular tolerance: - Difference between the investigational products with respect to ocular comfort score at baseline Day 1 and Day 22 - Difference between investigational products with respect to conjunctival hyperaemia at baseline Day 1 and Day 22 b) Safety: Difference between investigational products with respect to general safety as assessed by occurence of adverse events.;Timepoint(s) of evaluation of this end point: Day 1 (baseline) and Day 22 (under treatment) | — |
Countries
Austria, Hungary, Poland
Contacts
Public ContactVan Van Khov
Azad Pharma AG
Outcome results
None listed