24-Hour Intraocular Pressure Control Obtained With the Bimatoprost/Timolol Fixed Combination Compared With Latanoprost as First Choice Therapy in Subjects With Exfoliation Syndrome, or Exfoliative Glaucoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- 24-hour IOP reduction between the two medications
研究概览
简要总结
The primary objective of this crossover 24-hour Intraocular Pressure (IOP) trial is to compare the control obtained after 3 months of therapy with the bimatoprost/timolol fixed combination (BTFC, Ganfort) given once in the evening (20:00) versus latanoprost (Xalatan) administered once in the evening (20:00) in newly-diagnosed patients with exfoliation syndrome (XFS) and ocular hypertension, or exfoliative glaucoma (XFG) previously untreated and IOP greater than 29 mm Hg.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has exfoliation syndrome with ocular hypertension, or exfoliative glaucoma and is older than 29 years
- •Patient is newly diagnosed, or currently untreated and exhibits untreated morning IOP (2 separate IOP readings at 10:00)greater than 29 mm Hg in the study eye
- •Study patients should have mild to moderate exfoliative glaucoma (VF loss <12 dB; cupping 0.8 or less)
- •Patient with exfoliation syndrome should fulfill the IOP criterion (IOP > 29 mm Hg at 10:00)
- •Patient deemed by investigator to require significant IOP reduction to obtain desired target IOP
- •Patient agrees to be treated for at least 3 months with latanoprost and bimatoprost/timolol fixed combination drops dosed in the evening
- •In study eye distance best corrected Snelen visual acuity greater than 1/10
排除标准
- •Contraindications to therapy with latanoprost, bimatoprost, or β-blockers
- •History of non-adherence or previously recorded evidence of lack of response (<10% morning IOP reduction) to any antiglaucoma medication
- •Patient can not understand the instructions and adhere to medications
- •Patient is a female of childbearing potential or lactating mother
- •Past history of trauma, inflammation, surgery, past use of steroids (within 2 months), severe dry eyes and use of contact lenses
- •Signs of ocular infection, except blepharitis, or corneal abnormality that may affect IOP measurements
- •The other eye can not receive the same therapy, or remain without medical therapy
- •Closed angles
研究组 & 干预措施
Bimatoprost/Timolol drops
The patients will be treated with bimatoprost/timolol fixed combination therapy
干预措施: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring (Drug)
Bimatoprost/Timolol drops
The patients will be treated with bimatoprost/timolol fixed combination therapy
干预措施: Latanoprost, 24-hour intraocular pressure monitoring (Drug)
Latanoprost drops
The patients will be crossed over to therapy with latanoprost
干预措施: Bimatoprost/Timolol, 24-hour intraocular pressure monitoring (Drug)
Latanoprost drops
The patients will be crossed over to therapy with latanoprost
干预措施: Latanoprost, 24-hour intraocular pressure monitoring (Drug)
结局指标
主要结局
24-hour IOP reduction between the two medications
时间窗: 3 months
Bimatoprost/Timolol will obtain a statistically greater 24-hour IOP reduction than latanoprost and the mean 24-hour IOP difference between the two medications will be clinically meaningful (at least 2 mm Hg).
次要结局
未报告次要终点
研究者
AGP Konstas
Professor in Ophthalmology
Aristotle University Of Thessaloniki