A trial that aims to compare the efficacy and safety of two treatments for open-angle glaucoma or ocular hypertension. Both drugs contain the same active substance (Brinzolamide 10 mg/ml Eye Drops, Suspension). The patients will be followed for a certain period of time and will receive on a random principle either the new drug or the authorized drug. The trial will be conducted in several centers. The investigators will not know which patient is using a test and which reference product.
- Conditions
- GLAUCOMA , OCCULAR HYPERTENSIONTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2022-002524-12-BG
- Lead Sponsor
- AZAD Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 244
• 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
• 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
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