跳至主要内容
临床试验/ISRCTN46696624
ISRCTN46696624已完成未知

Prostaglandin F2-alpha eye drops (BIMAtoprost) in thyroid eye disease: a randomised controlled double blind crossover trial

Cardiff University (UK)0 个研究点目标入组 31 人开始时间: 2014年3月14日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
31

研究概览

简要总结

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30880626 (added 13/06/2019)

研究设计

研究类型
Interventional

入排标准

性别
All

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 >2 mm 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, intrauterine device (IUD) and condom, diaphragm with spermicide and condom

排除标准

  • 1. Age <18 years
  • 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

发起方
Cardiff University (UK)

相似试验