24-hour IOP Control With the Travoprost/Timolol Fixed Combination Compared With the Latanoprost/Timolol Fixed Combination, When Both Are Dosed in the Evening in Patients With Exfoliative Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
研究概览
简要总结
A crossover, randomized, single-masked study which compares the short-term (3 months) 24-hour IOP control and safety of travoprost/timolol fixed combination given once in the evening, versus that of latanoprost/timolol fixed combination given once in the evening in patients with exfoliative glaucoma. The primary objective of this trial is to compare the quality of 24-hour IOP control after 3 months of chronic therapy with these two medications.
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
- 21 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has XFG and is older than 29 years
- •The IOP without treatment is greater than 25 mm Hg and lower than 40 mm Hg at baseline (2 readings at 10:00)
- •Patient can be safely washed out without risk for significant deterioration
- •Distance best corrected Snelen visual acuity better than 0.1
- •No contraindication to prostaglandins or β-blockers
- •No history of lack of response (<10% reduction) to any medication
- •Patient can understand the instructions and comply to medications
- •Open normal appearing angles
- •No sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
排除标准
- •History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- •Patient is a female of childbearing potential or lactating mother
研究组 & 干预措施
Travoprost/timolol therapy
treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.
干预措施: treatment with latanoprost/timolol fixed combination (Drug)
Travoprost/timolol therapy
treatment with travoprost/timolol fixed combination drops once in the evening for 3 months. 24-hour pressure monitoring.
干预措施: latanoprost/timolol fixed combination drops (Drug)
Latanoprost/timolol therapy
Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
干预措施: treatment with latanoprost/timolol fixed combination (Drug)
Latanoprost/timolol therapy
Treatment with latanoprost/timolol fixed combination for 3 months. 24-hour pressure monitoring.
干预措施: latanoprost/timolol fixed combination drops (Drug)
结局指标
主要结局
Travoprost/timolol fixed combination will demonstrate better quality of 24-hour IOP control than latanoprost/timolol
时间窗: 3 months
次要结局
- Incidence of side effects with the two medications(3 months)
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki