A Crossover, Double-Masked Comparison Investigating the 24-Hour Intraocular Pressure Control With the Travoprost/Timolol Fixed Combination Versus Travoprost, When Both Are Given in the Evening, in Subjects With Primary Open-Angle Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean 24-hour IOP
研究概览
简要总结
This 8-week, crossover study will compare the quality of 24-hour IOP control with TTFC versus travoprost when both medications are dosed in the evening. Such a crossover comparison may determine the real efficacy of the new fixed combination versus travoprost monotherapy. The results should enhance the investigators understanding on the best dosing of TTFC and may influence its clinical use in Europe. Finally, the results would better delineate the future role of TTFC in glaucoma management after PG monotherapy, or instead of unfixed therapy with PG analogs and timolol. This study should assist the general ophthalmologist worldwide to plan optimal stepwise medical therapy.
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 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive adults with primary open-angle glaucoma (POAG) who exhibit a mean untreated IOP greater than 23 m Hg at baseline (10:00).
- •Patient has POAG and is older than 29 years
- •The IOP without treatment is greater than 23 mm Hg and lower than 38 mm Hg at baseline (2 readings at 10:00)
- •Patient can be safely washed out without risk for significant deterioration
- •Distance best corrected Snellen visual acuity better than 1/10
- •Patient can understand the instructions and comply to medications
- •Open normal appearing angles
排除标准
- •Contraindications to prostaglandins or β-blockers
- •History of lack of response (<10% reduction) to any medication
- •Female of childbearing potential or lactating mother
- •History of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- •Sign of ocular infection, except blepharitis, corneal abnormality that may affect IOP measurements etc
研究组 & 干预措施
Travoprost/Timolol therapy
24-hour pressure monitoring after 3 months of chronic dosing with travoprost/timolol drops
干预措施: Travoprost/timolol fixed combination, travoprost (Drug)
Travoprost therapy
24-hour pressure monitoring after 3 months of chronic dosing with travoprost drops
干预措施: Travoprost/timolol fixed combination, travoprost (Drug)
结局指标
主要结局
Mean 24-hour IOP
时间窗: 3 months
次要结局
- Mean reduction from baseline(3 months)
- Mean fluctuation of 24-hour IOP(3 months)
- Individual IOP readings measured at 10:00 (± 1 hour) and at +4, +8, +12, +16 and +20 (± 1 hour) hours.(3 months)
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki