Efficacy and Safety of Latanoprost/Timolol Fixed Combination Dosed Twice Daily Compared to Once Daily in Patients With Primary Open Angle Glaucoma
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy: Intraocular pressure reduction
研究概览
简要总结
Intraocular pressure (IOP) is the most important modifiable risk factor to prevent and delay progression of glaucoma. IOP reduction has been proven to delay the onset and progression of glaucoma, and uncontrolled IOP is constantly associated with progression of visual field loss.
Medical therapy is the first line in IOP reduction for Primary Open Angle Glaucoma (POAG). It is a known fact that glaucoma patients often require addition of a second antiglaucoma medications when disease progresses or tachyphylaxis occurs. It was reported that more than 50% of patients require 2 or more medications to achieve optimum IOP control.
Nevertheless, compliance and adherence are often impaired with multiple-drug therapy. Combining two ocular hypotensive agents in one bottle may help patients adhere to therapeutic regimen by reducing the number of medications used and the total number of doses administered.
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
- 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
- 否
入选标准
- •Age 18 and above
- •Able to provide informed consent
- •Diagnosed as having unilateral or bilateral, mild to moderate POAG
- •The POAG treated with only two antiglaucoma
排除标准
- •Advanced POAG
- •Patient with contraindication for topical use of a-blocker and prostaglandin analogue
- •Patient with contraindication for systemic use of a-blocker
- •Patient on systemic use of a-blocker such as metoprolol, propranolol, atenolol
- •History of orbital or ocular trauma.
- •History of cataract surgery less than 6 months.
- •History of previous ocular surgery; e.g. vitreoretinal surgery, corneal transplantation or glaucoma surgery
- •Any active eye infections or corneal ulceration.
- •Patient with ocular surface disease
- •Other ocular disease that might interfere with IOP measurements or result
- •Precious eye i.e patient with only one good eye
- •Contact lens is not allowed within 1 week before the start of study and during the study
研究组 & 干预措施
once daily group
Latanoprost/Timolol Fixed Combination (LTFC) will be administered once daily for 4 weeks. The IOP will be determined on Day 14 and 28. The following examinations will be performed: evaluation of conjunctiva hyperemia, anterior chamber reaction, applanation tonometry, measurement of blood pressure and heart rate.
For once daily dosing, the eye drops will be instilled at 8am every morning. The IOP will be taken at 9am-12pm on study day.
干预措施: Latanoprost/Timolol (Drug)
twice daily group
Latanoprost/Timolol Fixed Combination (LTFC) will be administered twice daily for 4 weeks. The IOP will be determined on Day 14 and 28. The following examinations will be performed: evaluation of conjunctiva hyperemia, anterior chamber reaction, applanation tonometry, measurement of blood pressure and heart rate.
For twice dosing, the eye drops will be instilled at 8am and 8pm. The IOP will be taken at 9am-12pm on study day.
干预措施: Latanoprost/Timolol (Drug)
结局指标
主要结局
Efficacy: Intraocular pressure reduction
时间窗: 4 weeks
IOP reduction with LTFC given once and twice daily in POAG patients
次要结局
- Safety: Side effects(4 weeks)
研究者
Norshamsiah Md Din
Associate Professor
Universiti Kebangsaan Malaysia Medical Centre