GLAUCOMA , OCCULAR HYPERTENSION
Conditions
Interventions
Trade Name: AZOPT
Product Name: AZOPT
Pharmaceutical Form: Eye drops, suspension
Product Name: BRINZOLAMIDE 10MG/ML EYE DROPS SUSPENSION PRESERVATIVE FREE
Pharmaceutical Form: Eye drops, suspension
I
Sponsors
AZAD Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or Female patients aged between 18 and 75 years at time of Informed Consent; • Elevated IOP / primary open angle glaucoma (irideocorneal angle > 30°) in at least one eye: mean diurnal IOP pre-treatment (measured at approximately 8 am and 10 am must be equal or higher than 22 mmHg, and equal or lower to 35 mmHg (untreated, i.e. naïve or after washout); • In case of bilateral open-angle glaucoma/ocular hypertension the difference of IOP between both eyes is =5 mmHg; • Best Corrected Visual Acuity (BCVA) 20/100 (Snellen chart) (corresponding to logMAR score of = + 0.7 LogMar or = 0.2 in decimal value) or better in both eyes (OR the affected eye) at Screening/Visit 1; • Patient not on any ophthalmic pressure-lowering medication or patient who is in the condition not to suffer any untoward effects by withdrawal from current pressure-lowering medications for the washout period(s); • Patient not using any topical ophthalmic medication other than artificial tears; • 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. • Negative urine pregnancy test at Screening and Visit 1 for women of childbearing potential; • Willingness to use a reliable and acceptable method of contraception for the women of childbearing potential: - IUD, inserted at least 3 months prior to the study initiation; - Barrier method (condom, spermicide-containing diaphragm) applied at least 14 days prior to the first IMP application, in the course of the study and at least 4 days after the last administration; - Hormonal contraception with use initiation at least 14 days prior to administration of the first IMP application and at least 4 days after the last application of the IMP; - Sexual abstinence for at least 60 days prior to randomization in the study, in the course of the study and at least 4 days after its completion (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not considered as an acceptable methods of contraception; - Surgical sterilization (bilateral ligation of the uterine tubes, hysterectomy, bilateral ovariectomy or vasectomy of the partner) with no less than a 6-month history; - Menopause with no less than a 2-year history prior to the study initiation. • In the investigator's opinion the patient's general health conditions is not interfering with participation in the study; • In the investigator's opinion, the patient is capable of giving informed consent; • In the investigator's opinion, the patient is able to understand the provided information, able to attend all visits, willing and likely to fully comply with study procedures and restrictions. 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 214 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Advanced glaucoma defined by horizontal and vertical cup/disc ratio (C/D) >0.8 in either (OR the affected) eye at Screening; • Visual field loss in either (OR the affected) eye (sensitivity =10 decibel [dB] in at least 2 of the 4 visual field test points closest to the point of fixation), measured within 6 months prior to Screening, which in the opinion of the investigator is functionally significant; • Central Corneal Thickness (CCT) >620um in either (OR the affected) eye as measured by pachymetry; • Patients with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and patients with angle closure, congenital, and secondary glaucoma, and patients with history of angle closure in either eye; • Any contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to sulfonamides or to any component (active substances or excipients) of the IMPs; • Use at any time prior to Screening/Visit 1 of an intraocular corticosteroid implant; • Use within 3 months prior to Screening/Visit 1 of any ocular glucocorticoids; • Use within 4 weeks prior to Screening/Visit 1 of any of following: - systemic corticosteroids; - high dose salicylic therapy (stable daily dose = 325 mg aspirin or equivalent); - monoamine oxidase (MAO) inhibitor therapy; - any antidepressant which affects noradrenergic transmission (e.g., tricyclic antidepressants, mianserin); - adrenergic-augmenting psychotropic drug (e.g., desipramine, amitriptyline); - any other medication that augments adrenergic response or precludes use of an alpha-adrenergic agonist. • Use within 6 months prior to Screening/Visit 1 of intravitreal or subtenon injection of ophthalmic corticosteroid; • Intraocular surgery (e.g., cataract surgery) within 3 months prior to Screening/Visit 1; • Any IOP reduction surgery within 3 months prior to Screening/Visit 1; • Planned ocular surgery of any kind within the study duration; • Chronic, recurrent, or current severe inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye; • Ocular infection or ocular inflammation in either (OR the affected) eye within 3 months prior to the Screening/Visit 1; • Ocular trauma in either (OR the affected) eye within 3 months prior to the Screening/Visit 1; • Clinically significant or progressive retinal disease (e.g., retinal degeneration, diabetic retinopathy, retinal detachment) in either (OR the affected) eye; • Other ocular pathology (including history of severe dry eye) in either (OR the affected) eye that may, in the opinion of the Investigator, preclude the safe administration of the IMPs; • Current or past history of severe hepatic or renal impairment or uncontrolled systemic disease; • Female patient who is pregnant, nursing, or planning a pregnancy or who is of childbearing potential and not using a reliable method of contraception; • Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the investigational agent (whichever is longer) prior to Screening; • Patient who suffers from another medical condition or who is receiving medication that in the Investigator's judgment would prohibit inclusion in the study; • Patient with any physical or behavioral disorder, which, in the opinion of the Investigator, may interfere with the correct self-therapy with the IMPs or compliance with the Study Protocol requirements; • History of known or suspecte
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of preservative-free Brinzolamide 10mg/ml eye drops suspension (test product) in lowering intra-ocular pressure (IOP) when compared to Brinzolamide 10 mg/ml eye drops suspension product (AZOPT®, Novartis) (reference product) at Week 12, in adult patients with OAG or OHT.;Secondary Objective: - To compare the tolerance of the test and reference products using an ocular comfort level score; - To compare the levels of conjunctival hyperaemia induced by test product and reference product; - To evaluate the general safety of the test product compared to the reference product; - To compare the efficacy of the test and reference products in terms of mean diurnal IOP changes from baseline and prior to Week 12.;Primary end point(s): The primary efficacy endpoint will be the difference between the test product when compared with the reference product of the mean diurnal IOP change of the study eye from baseline to Week 12 visit. The mean diurnal IOP change will be calculated as the average of the 08:00 am and 10:00 am time point measurements at each visit. The study eye will be identified as follows: - Patients suffers from unilateral glaucoma/ocular hypertension, the affected eye will be noted and monitored through the study. - If the patient suffers from bilateral glaucoma/ocular hypertension the IOP of both eyes will be measured at 8 am. The eye showing higher value will be established as study eye. - If both eyes show equal mean IOP measurement at 8 am, the IOP will be measured again at 10 am. The eye showing higher value will be established as study eye. - If both eyes show equal mean IOP measurement at 10 am, the right eye will be chosen as the study eye. ;Timepoint(s) of evaluation of this end point: 12 WEEK | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The difference between test and reference product in the mean (IOP of the study eye) change from baseline in the diurnal IOP at Visit 2; - The difference between test and reference product in the mean (IOP of the study eye) change from baseline in the diurnal IOP at Visit 3; - Safety Endpoint - The difference between the investigational products with respect to general safety as assessed by occurrence of treatment-emergent ocular and systemic AEs and ADRs in the two treatment arms during the study duration and 7 days after the treatment is discontinued. - Safety Endpoint – Ocular tolerance –The difference between the test and reference products with respect to ocular comfort level score and conjunctival hyperaemia at baseline (Day 1) and Week 2, Week 6 and Week 12. - Safety Endpoint - Proportions of patients with permanent treatment discontinuation due to ADRs during the study treatment period, in the two treatment arms. ;Timepoint(s) of evaluation of this end point: 1.BASELINE TO WEEK 2 2.BASELINE TO WEEK 6 3.BASELINE TO WEEK 12 | — |
Countries
Bulgaria
Contacts
Public ContactClinical Trials Department
Ramus Medical EOOD
Outcome results
None listed