跳至主要内容
临床试验/CTRI/2023/01/048794
CTRI/2023/01/048794进行中(未招募)4 期

A Prospective, Single-center, Single-Arm, Interventional Study to Assess the Efficacy(in alleviating the symptoms of ocular dryness) and Safety of Systane Ultra in subjectswith dry eye due to Computer Vision Syndrome (CVS)

Dr Agarwals eye hospital0 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
进行中(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

  • . Male/female of >=18 and <=45 years of age
  • 2. Participant who can and willing to provide written Informed Consent
  • 3. Participant more prone to computer use â?? daily computer / visual display unit
  • (VDU) use > 3 hours per day /15 hours per week
  • 4. Participant with minimum 3 months exposure to any VDU
  • 5. Participant with CVS-Q score >= 6
  • 6. Participant with OSDI Score 23-32 (both inclusive) with dry eye symptoms
  • 7. Participant with TBUT < 10 at the time of screening
  • 8. Participant is nonsmoker
  • 9. Participant/ patientâ??s legally acceptable representative having an ability to
  • understand the disease and its treatment and follow protocol requirements

排除标准

  • 1. Participants Ë? 18 or Ë? 45 years of age
  • 2. Participants using contact lenses within last 6 months
  • 3. Participants having a history of systemic disease, other ocular pathologies or on
  • prior treatment for the same
  • 4. Participants with a history of intra or extraocular surgery or planning to undergo
  • ocular or eyelid surgery
  • 5. Participants taking previous treatment with steroids, isotretinoin or
  • immunosuppressive drugs
  • 6. Patient with any other clinically significant illness
  • 7. Patient who has participated in another trial with an investigational drug within 6
  • months prior to this trial.
  • 8. Patient with any other condition, which as per the investigator would jeopardize the
  • outcome of the trial
  • 9. Patients who, in the judgment of the investigator, will be unlikely to comply with
  • the requirements of this protocol

研究者

发起方
Dr Agarwals eye hospital

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