2025-523227-22-00招募中3 期
A Therapeutic Non-Inferiority, Randomized, Observer-blind, Active-comparator, Two-arm, Parallel Group, Multi-center Clinical Trial for Comparing the Efficacy and Tolerability of a Generic Fixed Dose Combination of Brimonidine Tartrate 2 mg/ml + Timolol 5 mg/ml Eye Drops versus Combigan® 2 mg/ml + 5 mg/ml Eye Drops in the Treatment of Intraocular Pressure in Patients with Open Angle Glaucoma or Ocular Hypertension
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 39
- 主要终点
- The primary efficacy endpoint will be the difference between Test and Comparator in mean diurnal IOP change from baseline to week 12 visit after adjusting for baseline measurement (week 0).
研究概览
简要总结
To confirm the clinical non-inferiority of a new generic fixed dose combination of Brimonidine Tartrate 2 mg/ml + Timolol 5 mg/ml eye drops, phosphate free, preservative-free, compared to the comparator product Combigan® 2 mg/ml + 5 mg/ml eye drops in patients with elevated intraocular pressure (open angle glaucoma or ocular hypertension) by examining the average change of diurnal intraocular pressure (IOP) from end of study to baseline in order to compare the two study arms.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •male or female, of any race and ≥18 years of age
- •willing to provide voluntarily written informed consent and data protection declaration before any clinical trial related procedure is performed
- •diagnosed of unilateral or bilateral open angle glaucoma (including open-angle glaucoma with pseudoexfoliation or pigment dispersion) or ocular hypertension
- •average IOP ≥ 22 mm Hg and ≤ 34 mm Hg measured at 08:00 am, 12:00 am and 04:00 pm pre-treatment at baseline in at least one eye
- •without treatment for open-angle glaucoma with IOP-lowering drugs, for at least 4 weeks
- •best-corrected visual acuity ≥20 of 100 (Snellen) corresponding to logMAR ≤ 0.7 in the study eye
- •females who participate in the study are either unable to gestate [i.e. post-menopausal (absence of menses for 12 months prior to drug administration), hysterectomy, bilateral oophorectomy, tubal ligation at least 6 months prior to drug administration] or at reproductive age; Females of reproductive age if sexually active, must be practicing an effective method of birth control throughout the study; reliable contraception methods are considered the following: • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal or transdermal • progestogen-only hormonal contraception associated with inhibition of ovulation oral, implantable or injectable • intrauterine device (IUD) • intrauterine hormone-releasing system (IUS) • bilateral tubal occlusion • vasectomised partner • sexual abstinence
- •expected by the investigator that IOP will remain controlled under treatment without optic nerve damage or progression of visual field loss
- •patients with controlled arterial blood pressure according to the investigator’s opinion
- •able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits
排除标准
- •history of chronic or recurrent inflammatory eye disease (i.e. scleritis, uveitis, herpes keratitis), ocular trauma within the past 6 months or ocular inflammation within the past 3 months or infections
- •a history of, or current other severe ocular pathology (including severe dry eye) in either eye, that would preclude the administration of a beta-blocker
- •a history of depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans
- •any uncontrolled systemic disease
- •current reactive airway disease including bronchial asthma or a history of bronchial asthma, or severe chronic obstructive pulmonary disease
- •severe acute allergic rhinitis
- •sinus bradycardia, sick sinus syndrome, sino-atrial block, second- or third-degree atrioventricular block not controlled with pace-maker
- •overt cardiac failure, cardiogenic shock
- •use at any time prior to baseline of intraocular corticosteroid implant
- •use within two weeks prior to baseline of: 1) topical ophthalmic corticosteroid, or 2) topical corticosteroid
- •use within one month prior to baseline of: 1) systemic corticosteroid, 2) monoamine oxidase (MAO) inhibitor therapy, 3) any antidepressant which affects noradrenergic transmission (e.g., tricylic antidepressants, mianserin) or 4) adrenergic-augmenting psychotropic drug (e.g., desipramine, amitriptyline)
- •severe central visual field loss (i.e., sensitivity ≤10 decibel [dB] in at least 2 of the 4 visual field test points closest to the point of fixation) in either eye
- •use within six months prior to baseline of intravitreal or subtenon injection of ophthalmic corticosteroid
- •underwent within twelve months prior to baseline: refractive surgery, filtering surgery or laser surgery for IOP reduction
- •pregnancy or breast-feeding or childbearing potential not protected by a highly effective contraceptive method of birth control
- •narrow-angle/angle-closure glaucoma
- •current participation or not yet completed period of at least 30 days since ending of another investigational device or drug trial(s)
- •unwillingness or inability to comply with the clinical trial procedures
- •severe illness or other condition that would make the patient, in the opinion of the Investigator, unsuitable for the study
- •unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons
- •who are legally incapacitated
- •who are legally detained in an official institute
- •treatment with local or systemic corticosteroids in non-stable doses in the last 30 days
- •compromised cornea or corneal abnormalities that will preclude accurate IOP-reading with an applanation tonometer
- •clinically significant or progressive retinal disease (e.g. retinal degeneration, diabetic retinopathy, retinal detachment) in either eye
- •intraocular surgery within the past 3 months
- •ocular laser surgery within the past 1 month
- •planned ocular surgery of any kind during study participation
- •extremely narrow or partially closed angle, cup/disk ratio >0.8
- •a history of, or current severe hepatic or renal impairment
- •treatment with oral carbonic anhydrase inhibitors (e.g., acetazolamide, methazolamide, topiramate, sultiame, zonisamide)
- •ocular treatment with any prostamide, prostaglandin, carbonic anhydrase inhibitor and pilocarpine
- •current use of topical, ocular, nonsteroidal anti-inflammatory drugs
- •any change in any systemic medication that could affect IOP within the last 30 days before the beginning of and during the study (e.g., clonidine, β-blockers etc.)
- •known hypersensitivity to beta-blockers
- •a history of allergic hypersensitivity or poor tolerance to any component of the eye drops used in this clinical trial
研究组 & 干预措施
Brimonidine-Timolol
Test
干预措施: Brimonidine-Timolol (Drug)
Combigan, 2 mg/ml + 5 mg/ml, krople do oczu, roztwór
Comparator
干预措施: Combigan, 2 mg/ml + 5 mg/ml, krople do oczu, roztwór (Drug)
结局指标
主要结局
The primary efficacy endpoint will be the difference between Test and Comparator in mean diurnal IOP change from baseline to week 12 visit after adjusting for baseline measurement (week 0).
The primary efficacy endpoint will be the difference between Test and Comparator in mean diurnal IOP change from baseline to week 12 visit after adjusting for baseline measurement (week 0).
次要结局
- Difference between Test and Comparator in mean diurnal IOP change from baseline to week 2 visit after adjusting for baseline measurement (week 0).
- Difference between Test and Comparator in mean diurnal IOP change from baseline to week 6 visit after adjusting for baseline measurement (week 0).
- Frequency of study drugs’ related adverse events.
研究者
Dr. Tobias Kohl
Scientific
OmniVision GmbH
研究点 (39)
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