Comparison of Benzalkonium Chloride-containing Latanoprost and Preservative-free Bimatoprost on Ocular Surface Disease in Glaucoma Patients: a Prospective Randomised Study
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
研究概览
简要总结
Participants were randomised to receive benzalkonium chloride-containing latanoprost (Xalatan) or preservative-free bimatoprost (Lumigan). Through this study, the investigators would like to analyze the impact of different antiglaucoma medications on ocular surface disease in glaucoma patients.
详细描述
The purpose of our study is to assess the effect of antiglaucoma medication on ocular surface disease in glaucoma patients before and after treatment with different antiglaucoma medication. All included patients are newly diagnosed with glaucoma and received no previous antiglaucoma treatment. Medical records will be collected prospectively from Sep. 15th 2019 to Aug. 31st 2022. The symptoms and signs of ocular surface disease in each individual will be assessed with questionnaire and clinical exams, including the basal Schirmer's test, non-invasive tear film breakup time, meibography, and in vivo confocal microscopy before and at 1, 3, 6 months after treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are not diagnosed with glaucoma and don't receive any ocular hypotensive eye drops at our clinic.
- •Patients accept the rules for follow-up visits for at least six months.
排除标准
- •Patients are with a history of ocular trauma.
- •Patients are with contact lens use.
- •Patients are diagnosed with secondary glaucoma.
- •Patients have significant diseases affecting the meibomian gland and ocular surface.
- •Patients have poor IOP control that required additional ocular hypotensive eye drops.
研究组 & 干预措施
Lumigan PF
Patients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic. Eligible patients then received 0.03% bimatoprost (preservative-free) (Lumigan PF, Allergan Inc., CA, USA).
干预措施: Lumigan PF; Xalatan (Drug)
Xalatan
Patients older than 20 years were recruited from the Glaucoma Clinic of National Taiwan University Hospital. Patients were considered eligible for enrolment if they were newly diagnosed with glaucoma and started to receive ocular hypotensive eye drops at our clinic. Eligible patients then received 0.005% latanoprost (containing 0.02% BAK as a preservative) (Xalatan, Pfizer, NY, USA).
干预措施: Lumigan PF; Xalatan (Drug)
结局指标
主要结局
The influence of glaucoma eye drops on ocular surface disease index (OSDI) in patients
时间窗: Change from Baseline OSDI at 4 month
次要结局
未报告次要终点