24-Hour Efficacy of Travoprost/Timolol Benzalkonium Chloride BAK Free Compared With Latanoprost/Timolol Fixed Combination Therapy in Subjects With Open-Angle Glaucoma Insufficiently Controlled With Latanoprost Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Mean 24-hour intraocular pressure reduction between the two medications
研究概览
简要总结
The primary objective of this crossover trial is to compare the 3-month, mean 24-hour intraocular pressure (IOP) control and safety obtained with two popular fixed combinations in glaucoma patients insufficiently controlled with latanoprost monotherapy. This study will compare the 24-hour efficacy of travoprost/timolol fixed combination without benzalkonium chloride given once in the evening, versus the latanoprost/timolol fixed combination given in the evening. It is assumed that travoprost/timolol fixed combination will provide better quality of 24-hour pressure control.
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
- 29 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open-angle glaucoma or exfoliative glaucoma
- •Patients who require additional IOP lowering on latanoprost monotherapy
- •Morning IOP greater than 20 mm Hg on latanoprost monotherapy
- •Untreated morning IOP greater than 26 mm Hg
- •Patients older than 29 years
- •Patients with early to moderate glaucoma (less than 14 decibel (dB) mean deviation visual field loss attributed to glaucoma and 0.8 or better vertical cup-to-disc ratio)
- •On therapy with latanoprost monotherapy for at least 3 months
- •Patients with a reliable visual field
- •Best corrected distance Snellen visual acuity >1/10
- •Corneal pachymetry within the 550 ± 50 μm range
- •Patients should understand the study instructions
- •Patients willing to attend all follow-up appointments and willing to comply with study medication usage
- •Patients who have open, normal appearing angles
排除标准
- •History of combined topical therapy
- •Contraindication to prostaglandins or timolol
- •History of ocular trauma or inflammation; intraocular surgery; severe dry eyes; use of contact lenses
- •Sign of ocular infection except for mild blepharitis
- •Any corneal abnormality that could have affected the measurement of IOP
- •Chronic use of topical corticosteroids in the last 3 months before entering the study
- •Current, or previous use of systemic corticosteroid treatment
- •Uncontrolled systemic disease
- •Change of a systemic medication during the study period
- •Women of childbearing potential or lactating mothers
- •Inability to understand the instructions and adhere to medications
研究组 & 干预措施
Travoprost/Timolol therapy
Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
干预措施: Travoprost/timolol therapy (Drug)
Travoprost/Timolol therapy
Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
干预措施: Latanoprost/Timolol therapy (Drug)
Latanoprost/Timolol therapy
Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
干预措施: Travoprost/timolol therapy (Drug)
Latanoprost/Timolol therapy
Enrolled patients will be treated for 3 months with travoprost/timolol drops administered once in the evening. 24-hour pressure monitoring will be carried out for this drug after 3 months of chronic dosing. All patients will be crossed over to therapy for 3 months with latanoprost/timolol fixed combination drops administered once in the evening. Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
干预措施: Latanoprost/Timolol therapy (Drug)
结局指标
主要结局
Mean 24-hour intraocular pressure reduction between the two medications
时间窗: 3 months
Evaluation of 24-hour pressure every 4 hours at habitual position with calibrated Goldmann technology tonometer
次要结局
- rate of adverse events with the two medications(3 months)
- ocular surface indicators after 3 months of therapy with the two medications(3 months)
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki