Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Corneal staining test
研究概览
简要总结
Comparison of Efficacy and Ocular Surface Disease Assessment Between Monoprost and BAK-preserved Latanoprost in Glaucoma or Ocular Hypertensive Patients : Phase 4, Parallel Group Design, Investigator-blind, Active-control, Randomized, Multi-center Study
详细描述
Not provided
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IOP >/= 15mmHg and < 40 mmHg in each eye using Goldmann applanation tonometry at visit 2
- •Written consent voluntarily to participate in this clinical trial
排除标准
- •Patients with closed-angle, congenital glaucoma or secondary glaucoma caused by steroid drugs, etc.
- •best-corrected visual acuity 20/80 or less
- •Patients who have ongoing medical history of ocular inflammation
- •central corneal thickness is not in between 470um and 591um.
- •Patients who have received lacrimal duct procedure within the last 3 months or who have plans to have it.
- •pregnant or nursing women
研究组 & 干预措施
Monoprost (preservative-free latanoprost eye drop)
latanoprost : 1 drop once a day for 12 weeks to target eyes
干预措施: Monoprost (Drug)
Xalatan (preserved latanoprost eye drop)
latanoprost : 1 drop once a day for 12 weeks to target eyes
干预措施: Xalatan (Drug)
结局指标
主要结局
Corneal staining test
时间窗: (12-week-point)
The degree of staining of the cornea after blue fluorescein staining under the light of cobalt blue using a yellow filter was evaluated according to the Oxford grading system (0 to 5, the higher the worse)
Conjunctival staining test
时间窗: (12-week-point)
The conjunctiva was divided into 6 areas and evaluated after the same staining method according to the Oxford grading system (0 to 3, the higher the worse)
Ocular surface disease index (OSDI)
时间窗: (12-week-point)
The ocular surface was assessed using OSDI scoring questionnaire (0 to 100, the higher the worse)
Compliance check
时间窗: (12-week-point)
Compliance of the drug administration has been check through the subject's self description (0 to 100, the higher the better)
次要结局
- Conjunctival staining test((4-week-point))
- Corneal staining test((4-week-point))
- IOP (intraocular pressure)((4- / 12-week-point))
- Tear break up time (TBUT)((4- / 12-week-point))
- Limbal and bulbar hyperemia((4- / 12-week-point))
- Ocular surface disease indext (OSDI)((4-week-point))