EUCTR2022-002524-12-BG招募中1 期
A prospective, phase III, multicenter, randomized, investigator-blinded, two-arm, parallel groups, non-inferiority clinical trial for the comparison of efficacy and safety of a preservative-free Brinzolamide 10mg/ml eye drops suspension (Brinzolamide 10mg/ml Eye Drops Suspension Preservative Free) as a test product versus AZOPT® 10 mg/ml eye drops suspension as reference product in the treatment of elevated intraocular pressure in adult patients with open-angle glaucoma or ocular hypertension
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 244
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •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
- •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:
- 另有 4 项未显示
排除标准
- •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;
- 另有 13 项未显示
研究者
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