Clinical Trial: Acupuncture for Dry Eye Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study

Brief Summary: This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.

Detailed Summary:
Sponsor: Korea Institute of Oriental Medicine

Current Primary Outcome: Ocular Surface Disease Index : OSDI [ Time Frame: Visit 11 (after 3 weeks from baseline) ]

The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants checked at a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores will be calculated according to the following formula: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100. Mean difference of the OSDI scores was calculated from the OSDI scores between Visit 11 and baseline.


Original Primary Outcome: Ocular Surface Disease Index : OSDI [ Time Frame: Visit 11 (after 3 weeks from baseline) ]

Current Secondary Outcome:

  • Visual Analogue Scale of Self Symptoms [ Time Frame: every visit ]
  • Schirmer 1 Test [ Time Frame: visit 1,10 ]
  • Tear Film Break-up Time : BUT [ Time Frame: Visit 1, 10 ]
  • Medication Quantification Scale (MQS) [ Time Frame: every visit ]
  • General Assessment [ Time Frame: visit 11 ]


Original Secondary Outcome:

  • Visual Analogue Scale of Self Symptoms [ Time Frame: every visit ]
  • Schirmer 1 Test [ Time Frame: visit 11 ]
  • Tear Film Break-up Time : BUT [ Time Frame: Visit 1, 10 ]
  • Medication Quantification Scale (MQS) [ Time Frame: every visit ]
  • General Assessment [ Time Frame: visit 11 ]


Information By: Korea Institute of Oriental Medicine

Dates:
Date Received: August 31, 2009
Date Started: September 2009
Date Completion:
Last Updated: December 17, 2010
Last Verified: September 2010