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临床试验/EUCTR2014-000540-15-GB
EUCTR2014-000540-15-GB进行中(未招募)1 期

Prostaglandin F2-alpha eye drops (Bimatoprost) in thyroid eye disease: a randomised controlled double blind crossover trial - BIMA STUDY: Bimatoprost Eye Drops in Thyroid Eye Disease

Cardiff University0 个研究点目标入组 31 人开始时间: 2014年4月1日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
31

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • 1.Stable TED with no reported change in proptosis for at least 6 months
  • 2.Clinical activity score <3
  • 3.Proptosis (subjective unilateral proptosis confirmed by asymmetry in exophthalmometry of >2mm OR greater than 20 mm on exophthalmometry measurement in one eye)
  • 4.Euthyroid (FT3 and FT4 in the reference range).
  • 5. If female, must be using a reliable form of contraception during the trial, e.g. oral contraceptive and condom, intra-uterine device (IUD) and condom, diaphragm with spermicide and condom.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 20
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 11

排除标准

  • 1.Age <18 yrs
  • 2.Dysthyroid optic neuropathy unless previously treated
  • 3.Pregnancy or lactation
  • 4.Previous Corneal Herpes Simplex infection
  • 5.On therapy for glaucoma or intraocular hypertension
  • 6.Less than 6 months from prior steroid use
  • 7.Aphakia, pseudophakia with torn posterior lens capsule or anterior chamber lenses
  • 8.Patient with risk factors for cystoid macular oedema, iritis or uveitis
  • 9.Severe Asthma (risk of severe allergic reaction to medication).
  • 10.Previous allergy to Bimatoprost or preservative.

研究者

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