Effects of Latanoprost, Bimatoprost and Travoprost in Patients With Latanoprost-resistant Glaucoma
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- intraocular pressure
研究概览
简要总结
Intraocular pressure (IOP) is considered to be the main risk factor for progression of glaucoma and therefore the main target of therapy. Pharmacologic treatment of glaucoma has changed considerably during the last decades due to the introduction of prostaglandin analogues. Three of these are commonly used in North America: latanoprost (Latanoprost T, Pfizer), Travoprost (Travatan TM, Alcon) and bimatoprost (Lumigan TM, Allergan).
There have been several studies to evaluate their effectiveness. The three seem to be equivalent, according to the only study that has compared the molecules. Latanoprost is employed initially, due to its paucity of side effects when compared to the other two analogues. However, if it is not effective, several studies ahve shown that a result is possible using either travoprost or bimatoprost. No study has been conducted to date systematically comparing the three molecules in cases of resistance to latanoprost. In actuality, the investigators patients will receive treatment identical to current practice with the exception of the group continuing with latanoprost. Several studies confirm the benefit of changing prostaglandin analogues if the first has not signficantly decreased the IOP (Palmberg et al. 2004). Each prostaglandin has unique properties which may cause the mechanism of action to vary slightly among patients. (cf. Pharmacological Aspects)
The goal of the study is thus to evaluate the efficaciousness of latanoprost, bimatoprost and travoprost in their IOP-lowering capacity in patients who do not initially respond to latanoprost.
详细描述
Research question:
What is the effectiveness of latanoprost, bimatoprost and travoprost in patients whose intraocular pressure does not decrease by at least 20% while undergoing treatment with latanoprost ?
Secondary questions:
1- What is the percentage of glaucoma patients who are resistant to latanoprost ? 2- Which prostaglandin is the most effective in decreasing intraocular pressure in cases of resistance to latanoprost ?
Research Project Goals :
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed with ocular hypertension or primary open-angle glaucoma who have never received treatment.
- •Age 18 or older and able to give informed consent
排除标准
- •Patients with intraocular inflammation of any etiology
- •Patients with advanced glaucoma, defined by severe optic nerve damage and/or visual field deficit.
- •Patients having had intraocular surgery in the last 4 weeks
- •Patients undergoing treatment with ophthalmic solution of any kind
- •Patients unable to give informed consent to participate in the research project,including those suffering from psychiatric illness resulting in impaired judgement
- •Monophthalmia or anophthalmia
- •Pregnant or nursing patients
- •Patients status post ocular surgery, with the exception of cataract extraction surgery
研究组 & 干预措施
ophtalmic solution,
Travoprost, latanoprost and bimatoprost, ophthalmic solution are topical medications used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure. they are synthetic prostaglandin F 2α analogue (and prodrug for bimatoprost) that works by increasing the outflow of aqueous fluid from the eyes.
干预措施: Latanoprost, bimatoprost, travoprost (Drug)
ophtalmic solution,
Travoprost, latanoprost and bimatoprost, ophthalmic solution are topical medications used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure. they are synthetic prostaglandin F 2α analogue (and prodrug for bimatoprost) that works by increasing the outflow of aqueous fluid from the eyes.
干预措施: travoprost, latanoprost and bimatoprost (Drug)
结局指标
主要结局
intraocular pressure
时间窗: 2 years
A drop of fluorescein sodium and benoxinate hydrochloride, USP (0.25%/0.4%) will be instilled in the patient's eyes, after which baseline IOP will be measured by Goldmann tonometry. The inter-measurement variability is +/- 2mmHg.
次要结局
未报告次要终点