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Acupuncture for Dry Eye Syndrome

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ClinicalTrials.gov Identifier: NCT00969280
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : September 20, 2010
Last Update Posted : December 21, 2010
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 1, 2009
Results First Submitted Date  ICMJE September 17, 2010
Results First Posted Date  ICMJE September 20, 2010
Last Update Posted Date December 21, 2010
Study Start Date  ICMJE September 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
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 Measures  ICMJE
 (submitted: August 31, 2009)
Ocular Surface Disease Index : OSDI [ Time Frame: Visit 11 (after 3 weeks from baseline) ]
Change History Complete list of historical versions of study NCT00969280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2009)
  • 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 Measures  ICMJE
 (submitted: August 31, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Dry Eye Syndrome
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Syndromes
Intervention  ICMJE
  • Device: Standardized Acupuncture

    Acupuncture treatment will be applied 3 times per week, total 9 times for 3 weeks.

    According to the guideline of WHO standard acupuncture point locations in the western pacific region, acupuncture treatment will be offered in all 17 acupoints: both BL2, GB14, TE23, Extra-1(Taiyang), ST1 and GB 20, and GV23, and Left SP3, LU9, LU10 and HT8, which are located in periorbit, forehead or temple of the head and Lt. forearm and back of the Lt. foot by a disposable 20*30mm (Dongbang Co., korea) acupuncture needle.

    All the acupuncture needles will be inserted, induced strong 'deqi' sensation and retained for 20 minutes.

  • Device: Non-acupuncture point shallow penetration acupuncture

    Acupuncture treatment will be applied 3 times per week, all 9 times for 3 weeks.

    Acupuncture treatment will be offered in 17 non-acupuncture points by a disposable 20*30mm acupuncture needle. A strong 'deqi' sensation will not be induced, but inserted acupunctures will be leaved for 20 minutes.

Study Arms  ICMJE
  • Experimental: Standardized Acupuncture group
    Intervention: Device: Standardized Acupuncture
  • Placebo Comparator: Non-acupoint shallow penetration group
    Intervention: Device: Non-acupuncture point shallow penetration acupuncture
Publications * Kim TH, Kim JI, Shin MS, Lee MS, Choi JY, Jung SY, Kim AR, Seol JU, Choi SM. Acupuncture for dry eye: a randomised controlled trial protocol. Trials. 2009 Dec 3;10:112. doi: 10.1186/1745-6215-10-112.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 23, 2009)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2009)
30
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:

    1. Patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
    2. Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test

Exclusion Criteria:

  • Those who have defects of eyelid or eyelashes
  • Those who have acute infection of eyelid, eyeball or accessories of eye
  • Those who have Stevens-Johnson syndromes or Pemphigoids
  • Those who have Vitamin A deficiency
  • Those who have any defects of eye or accessories of eye by external injuries
  • Those who have undergone any surgical operation for eye during last 3 months
  • Those who are using contact lens
  • Those who have any difficulties about eye opening or eye closing due to facial palsy
  • Those who have undergone punctual occlusion surgery
  • Those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops)
  • Those who have systemic immune therapy
  • Those who are pregnant or have any plan for pregnancy
  • Those who are not appropriate to this study by investigators decision
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00969280
Other Study ID Numbers  ICMJE KI0906
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Choi, sun-mi/Principal Investigator, Department of Medical Research, Korea Institute of Oriental Medicine
Study Sponsor  ICMJE Korea Institute of Oriental Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sunmi Choi, doctor Korea Institute of Oriental Medicine
Principal Investigator: Taehun Kim, Doctor Korea Institute of Oriental Medicine
Principal Investigator: Mi-suk Shin, Master Korea Institute of Oriental Medicine
PRS Account Korea Institute of Oriental Medicine
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP