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) ]
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