An Open-label, Randomized, Controlled, Comparative Efficacy and Safety Study of Dorzotimol Eye Drops, 20 mg/mL + 5 mg/mL (JGL dd, Croatia), vs. Cosopt® Eye Drops, 20 mg/mL + 5 mg/mL (Merck Sharp & Dohme, France) in Patients With POAG
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Mean IOP change from baseline
研究概览
简要总结
The goal of this study is to compare efficacy and safety of Dorzotimol eye drops, 20 mg/mL + 5 mg/mL manufactured by JADRAN-GALENSKI LABORATORIJ d.d. (Croatia) aimed at lowering elevated IOP in patients with ocular hypertension and primary open-angle glaucoma (POAG) versus Cosopt® eye drops, 20 mg/mL + 5 mg/mL manufactured by Laboratoires Merck Sharp & Dohme-Chibret, France. The main questions it aims to answer are:
- if the efficacy of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal;
- if the safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma is equal.
A total of 110 participants were screened and randomized 1:1 to the investigational drug (Dorzotimol) group or the reference drug (Cosopt) group. 55 patients were recruited in each group.
Researchers compared the investigational drug (Dorzotimol) group with the reference drug (Cosopt) group to see if the efficacy and safety of the investigational drug and the reference drug in patients with ocular hypertension and primary open-angle glaucoma are equal.
详细描述
Study Title:
An open-label, randomized, controlled, comparative efficacy and safety study of Dorzotimol eye drops, 20 mg/mL + 5 mg/mL, manufacturer: JADRAN - GALENSKI LABORATORIJ d.d., Croatia, vs. Cosopt® eye drops, 20 mg/mL + 5 mg/mL, manufacturer: Laboratoires Merck Sharp & Dohme-Chibret, France, in patients with primary open-angle glaucoma.
Protocol No. DORZOTIMOL-10/2015, version No. 1.2 of 16.05.2017. RCT No. 632 of 09.09.2016.
Investigators:
- Abdulaeva Elmira Abdulaevna (Test facility No.4)
- Eryomina Alyona Victorovna (Test facility No.6)
- Lisitsyn Alexey Borisovich (Test facility No.7)
- Doga Alexander Victorovich (Test facility No.9)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Females or males in the age bracket of 18 to 75 years.
- •Established stage I and II primary open-angle glaucoma in one or both eyes.
- •Intraocular pressure (IOP) level: 22-36 mm Hg (by Goldmann applanation tonometry).
- •Visual acuity 0.3 or better on the tested eye.
- •Taking topical prostaglandin analogs as monotherapy at least 3 months prior to the enrollment into the study and poor IOP control (> 21 mm Hg) or failure to achieve the target IOP, as estimated by the physician.
- •Patients who have signed an informed consent to participate in the study.
- •For females of child-bearing potential - a negative pregnancy test and consent to use reliable contraception methods throughout the study
排除标准
- •Contraindications or hypersensitivity to the active ingredients (dorzolamide and/or timolol) or excipients.
- •The only eye.
- •Visual acuity ˂ 0.3 after correction.
- •An active infectious inflammatory process on the tested eye within 3 months prior to pre-study medical examination.
- •Pronounced visual field defects (III and IV stage open-angle glaucoma).
- •IOP > 36 mm Hg or < 22 mm Hg as at the IOP measuring at 11:00 a.m. (±1 h) in any of the eyes on the screening visit day.
- •Closed or nearly closed anterior chamber angle (ACA) or history of acute angle close.
- •Surgical and laser eye interventions over the last 3 months.
- •Manifest ocular media opacification hindering the treatment efficacy evaluation.
- •Other eye diseases that may affect dynamics of the parameters used for the treatment efficacy evaluation.
- •Inflammatory conditions of the eye and appendages (blepharitis, conjunctivitis).
- •Corneal dystrophies.
- •The patient's participation in another clinical trial for the last 3 months.
- •Sinus bradycardia.
- •Second-degree and third-degree AV block.
- •Cardiogenic shock.
- •Decompensated cardiovascular diseases (angina pectoris > functional class II, arterial hypertension [systolic pressure > 140 mm Hg, diastolic pressure > 90 mm Hg]), apparent heart failure.
- •Severe renal failure (CC < 30 mL/min).
- •Airway hyperresponsiveness, bronchial asthma, history of bronchial asthma, severe chronic obstructive pulmonary disease.
- •Any other systemic or mental disorder/condition (unmanageable arterial hypertension, decompensated diabetes mellitus, severe renal impairment, hyperchloremic acidosis) or clinically relevant abnormal laboratory tests at screening that, in the Investigator's opinion, may put a patient to a significant risk, or compromise the study results, or appreciably affect the possibility for the patient to participate in the study.
- •A patient who is unlikely to comply with the protocol requirements, e.g., is undisposed to cooperation, and is unlikely to complete the study.
- •Females and males of reproductive age refusing to use efficacious contraception methods.
- •Females during pregnancy and breastfeeding
研究组 & 干预措施
Patients with primary open-angle glaucoma receiving Dorzotimol eye drops, 20 mg/mL + 5 mg/mL
Dosing schedule b.i.d., 12 weeks
干预措施: Dorzotimol eye drops, 20 mg/mL + 5 mg/mL (Drug)
Patients with primary open-angle glaucoma receiving Cosopt eye drops, 20 mg/mL + 5 mg/mL
Dosing schedule b.i.d., 12 weeks
干预措施: Cosopt eye drops, 20 mg/mL + 5 mg/mL (Drug)
结局指标
主要结局
Mean IOP change from baseline
时间窗: 12 weeks
Mean IOP change from baseline on visit 5 comparing with visit 0
次要结局
- IOP reduction rate greater than 20%(12 weeks)
- IOP reduction rate greater than 30%(12 weeks)
- IOP reduction rate to the target level of ≤ 18 mm Hg(12 weeks)