Comparative Evaluation of Intraocular Pressure During the 24 Hour in Patients Affected by Primary Open-angle Glaucoma and Ocular Hypertension: Latanoprost 0.005% Versus Tafluprost 0.0015% Ophthalmic Solutions
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Intraocular Pressure
研究概览
简要总结
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Main objective is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.
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Secondary objectives will be the comparison between Latanoprost 0.005% and Tafluprost 0.0015% ophthalmic solution about:
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Mean 24-hour IOP values after three months of treatment
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IOP values at these time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients > 45 years
- •Damage of the optic nerve and alterations of the visual field in case of POAG, no defects at the optic nerve and at the visual field in case of OHT
- •Untreated IOP > 24 mm Hg but < 32 mm Hg in at least one eye at baseline (10AM) and central corneal thickness between 500 and 600 μm
- •Negative pregnancy test (fertile women). Fertile women attending the study must express clear will to avoid pregnancy during all the study period and in the next three months
- •Informed consent before starting the study
排除标准
- •Secondary glaucoma (Sturge-Weber syndrome, Neurofibromatosis I, neovascular glaucoma, steroid glaucoma, etc)
- •Anterior segment anomalies (cataract, irido-corneal disgenesy, congenital ectropion uvae, etc)
- •Past ocular surgery, except cataract surgery in the previous 6 months
- •Corneal abnormalities that can influence IOP measurements (corneal oedema)
- •Positive pregnancy test or breast-feeding woman. No will to avoid pregnancy during all the study period and in the next three months
研究组 & 干预措施
LATANOPROST 0.005% EYEDROPS
Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry.
干预措施: LATANOPROST 0.005% EYEDROPS (Drug)
TAFLUPROST 0.0015% EYEDROPS
Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry.
干预措施: Goldmann and Perkins applanation tonometry (Device)
TAFLUPROST 0.0015% EYEDROPS
Tafluprost 0.0015% preservative-free ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means of Goldmann and Perkins applanation tonometry.
干预措施: TAFLUPROST 0.0015% EYEDROPS (Drug)
LATANOPROST 0.005% EYEDROPS
Latanoprost 0.005% preservative-added ophthalmic solution will be given once a day at the evening,in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. IOP values after three months of treatment will be evaluated throughout the 24-hour by the means Goldmann and Perkins applanation tonometry.
干预措施: Goldmann and Perkins applanation tonometry (Device)
结局指标
主要结局
Intraocular Pressure
时间窗: 24-hour
Primary endpoint of this crossover trial is to compare the ability of Latanoprost 0.005% preservative-added ophthalmic solution versus Tafluprost 0.0015% preservative-free ophthalmic solution, both given once a day at the evening, in reducing 24-hour intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) and/or ocular hypertension (OHT) at first diagnosis. First efficacy variable will be the difference between mean nocturnal IOP values after three months of treatment: nocturnal IOP is defined as the mean value between 2AM and 6AM measurements.
次要结局
未报告次要终点
研究者
Luciano Quaranta, MD
Associate Professor in Ophthalmology
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia