跳至主要内容
临床试验/CTRI/2021/11/038067
CTRI/2021/11/038067尚未招募3 期

COMPARATIVE EVALUATION OF AQUEOUS BASED AND OIL BASED 0.05% CYCLOSPORINE EYE DROPS IN THE TREATMENT OF MODERATE TO SEVERE DRY EYE DISEASE

AIIMS NEW DELHI0 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
3 期
状态
尚未招募
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)Aged 18 to 65 years old
  • 2)Moderate to severe DED
  • 3)Tear film break-up time (TBUT) <= 10seconds
  • 4)Corneal fluorescein staining (fluorescein staining score of >3 out of 15 in either eye)
  • 5)Schirmer I test <= 5mm/5min
  • 6)OSDI score > 23

排除标准

  • 1)History of ocular trauma,active blepharitis, infection, or inflammation not associated with DED during the 3-month period preceding the screening visit
  • 2)Patients with one blind eye
  • 3)Patients with history of active stage of any other concomitant ocular disease
  • 4)Ocular surgery within 3 months preceding the study
  • 5)History of hypersensitivity or any medical condition that contraindicates the use of the study drug or any of its compounds, or derivatives
  • 6)Patients taking any medication, topically or by any other route, which could interfere with the studyâ??s results, in the 3 days prior to trial, or until a time period in which residual effects could be present
  • 7)Contact lens wearer
  • 8)Fertile-age women with an inadequate birth-control method, as well as pregnant or breastfeeding women
  • 9)Legally disqualified or mentally disabled patients who cannot sign an informed consent
  • 10)Patients who cannot comply with medical appointments or with all protocol requirements
  • 11)Patients who disagree to participate in the trial

研究者

发起方
AIIMS NEW DELHI

相似试验