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临床试验/CTRI/2018/01/011121
CTRI/2018/01/011121已完成4 期

Analysis of comparative efficacy of a combination formula for a lubricant (Trehalose with sodium hyaluronate 1mg/mL) in the management of ocular surface conditions

arayana Nethralaya0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1.Males and Females
  • 2.Age 18 to 65 years,
  • 3.Mild to moderate dry eye disease as per:
  • i.OSDI score >18
  • ii.Schirmers II (with anaesthesia) >5 at 5 minutes, < 10 at 5 minutes
  • iii.TBUT < 7 seconds
  • iv.Corneal and conjunctival staining ( graded
  • by NEI and Van Bjisterveld grading)
  • 4.No use of any tear substitute for either eye in the preceding 6 weeks
  • 5.Willing to participate in the study
  • Inclusion criteria for Arm 2:
  • 6.All patients undergoing corneal refractive surgery without pre-existing dry eye
  • 7.Willing to participate in the study

排除标准

  • 1.BCVA distance < 6/60
  • 2.Severe blepharitis
  • 3.Eyelid malposition
  • 4.Corneal scar/ opacity
  • 5.Ocular Surface Squamous neoplasia (OSSN)
  • 6.Corneal neovascularisation or pannus
  • 7.cular allergy (except in paediatric population)
  • 8.Any ocular infection in the past 3 months
  • 9.Cataract surgery in the past 3 months
  • 10.Corneal or conjunctival procedure
  • 11.Ocular medications which are known to worsen dry eye like AGM
  • 12.Systemic conditions like collagen vascular disease, rheumatoid arthritis, Steven Johnson syndrome
  • Exclusion criteria for arm 2
  • 13.Pre-existing dry eye
  • 14.Corneal neovascularisation or pannus
  • 15.Ocular allergy (except in paediatric population)
  • 16.Any ocular infection in the past 3 months

研究者

发起方
arayana Nethralaya

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