NCT05857267已完成4 期
Phase IV, Multicenter, Double-blind, Randomized, Controlled, Parallel-group, Trial to Evaluate the Efficacy and Safety of Dozolamide 2%/Timolol 0,5% PF vs Dorzolamide 2%/Timolol 0,5% BAK-preserved in OAG or OH
Laboratorios Poen6 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年3月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 6
- 主要终点
- Ocular Surface Disease Symptoms
研究概览
简要总结
The goal of this study is to evaluate the tolerability of the new formulation of Dorzolamide+Timolol preservative free developed in OSD Aptar Pharma multidose system in comparison with Dorzolamide +Timolol BAK preserved ophthalmic formulation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years old
- •Patients with POAG and OH
- •PIO < 20 mmHg
- •Under treatment with Dorzolamide + Timolol BAK preserved at least 6 month after
- •OSDI > 13 & one of these ocular signs (BUT <6sec or Schirmer test < 5 mm/5min or corneal staining positive)
- •Corneal thickness between 520-580 um.
排除标准
- •Patient with severe respiratory diseases (asthma, COPD and other bronchospactic diseases).
- •Patient with cardiovascular diseases (Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock).
- •Severe renal impairment (CrCl <30 mL/min)
- •Progressive diseases of the retina other than glaucoma
- •Inflammation and/or infecctions active
- •Ocular surface syndrome other than Ocular Surface disease
- •Eyelid disorder
- •Systemic adminsitration of Betablockers or carbonic anhydrase inhibitors
- •Patient that requires another antigluacomatous eye drop other than fixed combination of Dorzolamide/Timolol
- •Patients who use regularly lubricant eye drops
- •Patient who use regularly contact lenses
- •Patient with autoinmune diseases
- •Patients who underwent kerato-refractive laser procedures, cornea or corneal surface surgery, including, but not limited to, LASIK and PRK, within 6 months prior to the baseline visit.
- •Patients who have undergone a laser procedure or intraocular surgery or extraocular in either eye within 6 months prior to the baseline visit.
- •Patients with severe central visual field loss in either eye based onclinical judgment of the investigator. For the Humphrey and Octopus perimeters, the severe loss The visual field is defined as a sensitivity less than or equal to 10 dB in at least two(2) of the four (4) visual field test points closest to the fixation point
- •Patients with known hypersensitivity to any of the components of bothdrugs under study.
- •Pregnant or lactating women.
- •Women of childbearing age who are not using a contraceptive method.
研究组 & 干预措施
Dorzolamide+Timolol PF
Experimental
Glaucotensil TD LC, Laboratorios Poen
干预措施: Dorzolamide / Timolol Ophthalmic Solution (Drug)
Dorzolamide + Timolol BAK
Experimental
Glaucotensil TD, Laboratorios Poen
干预措施: dorzolamide/timolol (Drug)
结局指标
主要结局
Ocular Surface Disease Symptoms
时间窗: Change from baseline in OSDI score at 24 weeks
OSDI questtionarie
次要结局
- Intraocular preassure(Change from baseline in PIO (mmHg) at 24 weeks)
- Break-up Time(Change from baseline BUT (seconds) at 24 weeks)
- SCHIRMER-ITEST(Change from baseline Shirmer test (mm) at 24 weeks)
- Treatment preference(Treatment preference with respect previous treatment at Week 24)
- Satisfaction questionnaire(Change from baseline of patient satisfaction at 24 weeks using a 5-point likert scale)
- Conjunctival Hyperemia(Change from baseline in porcentaje of patients with conjunctival hyperemia at 24 weeks)
- Best corrected visual acuity(Change from baseline visual acuity at 24 weeks)
研究者
研究点 (6)
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