NCT02136589已完成4 期
Effect of Non-steroid Anti-inflammatory Drug on Travoprost-induced Conjunctival Hyperemia and Intraocular Pressure Reduction in Normal Eyes
Tokyo University0 个研究点目标入组 40 人开始时间: 2008年9月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- IOP reduction
研究概览
简要总结
PG-analogues induce hyperemia as one of side effects in addition to IOP reduction.
IOP reduction is caused by direct FP receptor stimulation, but the cause of hyperemia is not clarified.
Because FP receptor stimulation induce intrinsic production of PGs, hyperemia or IOP reduction may be due to secondary induced PGs.
Thus, pretreatment with NSAID may affect the PG-analogue induced hyperemia or IOP reduction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •normal healthy eye
- •not applicable for IOP level
- •not wearing contact lenses
- •not applicable for the presence of the ocular surface diseases in case the treatment was not needed
排除标准
- •the eyes with chronic or recurrent uveitis, scleritis, corneal herpes infection
- •the eyes with the history of trauma, intraocular surgery, or Laser surgery within 6 months
- •the eyes with difficulty for the measurement of IOP with the applanation tonometer
- •the subjects with the allergy for PG-analogues or benzalkonium chloride
- •the subjects using the eyedrops excluding those in this study
- •the subjects treated with oral carbonic anhydrase inhibitor
- •the subject with Sjogren syndrome
- •the subjects who can not drop periodically
- •the subjects with the advanced glaucoma or the terminal stage of glaucoma
- •the subjects with the severe ocular complications
研究组 & 干预措施
Dicrofenac
Experimental
干预措施: dicrofenac and travoprost (Drug)
结局指标
主要结局
IOP reduction
时间窗: 1 day
effect of NSAID on IOP reduction by travoprost
次要结局
未报告次要终点
研究者
Makoto Aihara
Associate Professor
Tokyo University
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