Comparison of Bimatoprost and Lataprost in Patients With Chronic Angle-Closure Glaucoma: A Randomized Cross-Over Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period.
研究概览
简要总结
This is a randomized observer-masked cross-over study to compare the intraocular pressure (IOP) reducing effect of latanoprost with bimatoprost in subjects with chronic angle closure glaucoma (CACG) with raised IOP. Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline. The study will be carried out in at least 2 Singapore hospitals.
详细描述
Study eyes are defined as the eye(s) that fulfil all inclusion criteria but none of the exclusion criteria. The IOP will be measured by Goldmann applanation tonometry. The IOP at every visit will be taken by one examiner (masked) using the same slit lamp and tonometer. Three consecutive readings will be taken at each time and the mean of the three values used in the statistical analysis. The examiner will not be aware of the treatment the patient is on. The scale of the tonometer will be concealed to the examiner, and the IOP value read off by an assistant after the examiner determines the end point of tonometry.
At the Baseline visit and last visit of each Treatment period (Day 0, 42 and 84), IOP will be measured at 9 am and 5 pm. On Day 14 and 56, IOP will be measured only at 9 AM.
Thus, when the IOP is measured in the clinic at 9 AM, approximately 13 hours would have elapsed from the evening dose. This will coincide with the approximate peak effect of bimatoprost and latanoprost. The IOP reading at 5 PM will be the approximate trough for latanoprost and bimatoprost.
The IOP at the end of each Treatment period at 6 weeks (Day 42 and 84) will be utilized as the primary endpoint and a comparison of mean IOPs of the two treatment groups compared with the baseline (Day 0). For those who do not, for any reason, complete the 6-week assessment, their last IOP measure will be carried forward to provide the endpoint. However, the number of such cases within each treatment group will also be reported.
Prior to the trial, all patients will undergo clinical examinations and eye tests to determine eligibility.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral or bilateral CACG
- •Age more than or equal to 40 years old
- •Informed consent obtained at pre-study visit for all patients
排除标准
- •Secondary glaucoma such as uveitic or neovascular glaucoma
- •One eye eligible and fellow eye on unsuitable glaucoma treatment for this trial
- •IOP > 36 mmHg at Pre-study visit
- •Advanced glaucoma at risk of progression. This is defined as vertical cup-disc ratio > 0.9 and/or central visual field loss with a sensitivity of < 10 dB in any of the 4 visual field test points closest to fixation
- •Ocular infection or inflammation (except when related to peripheral iridotomy) within 3 months of the prestudy visit
- •On more than two anti-glaucoma medications
- •Previous intraocular surgery apart from laser peripheral iridotomy
- •Previous trauma to the eye, with angle damage
- •Ocular treatment with a steroid or non-steroidal anti-inflammatory medication within 1 month of the prestudy visit.
- •Use of contact lens.
- •Cornea infection or other cornea abnormalities.
- •Ocular diseases such as dry eye or retinal pathology.
- •Oral medications, such as diuretics, known to affect IOP.
- •Cerebrovascular, hepatic, renal, metabolic disease.
- •Known allergy to benzalkonium, or any other components of latanoprost/bimatoprost.
- •History of non-compliance.
- •Women who are pregnant, lactating, or of childbearing potential and not using adequate contraception.
- •Participated in another therapeutic medication study within the last 1 month.
研究组 & 干预措施
1
Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.
干预措施: Latanoprost-Bimatoprost (Drug)
2
Study subjects will be randomized to receive either latanoprost once daily or bimatoprost once daily for 6 weeks, after which they will be crossed over to the other medication for another 6 weeks. The IOP-reducing effect of the medications will be assessed by the reduction in IOP after each medication compared to baseline.
干预措施: Bimatoporost-Latanoprost (Drug)
结局指标
主要结局
The primary endpoint is defined as IOP reduction from baseline measurement (week 0) to the measurement at week 6 at each treatment period.
时间窗: 6 weeks
次要结局
- Incidence of side effects of each medication.(6 weeks after each treatment period)