Acupuncture for Dry Eye Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Device: Standardized Acupuncture
* Device: Non-acupuncture point shallow penetration acupuncture


Participation Criteria
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Eligibility Criteria
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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: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standardized Acupuncture group<br> | Device: Standardized Acupuncture<br>* 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.<br>|
| Placebo Comparator: Non-acupoint shallow penetration group<br> | Device: Non-acupuncture point shallow penetration acupuncture<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Surface Disease Index : OSDI | 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. | Visit 11 (after 3 weeks from baseline) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Dry eye syndrome, Ocular Surface Disease Index, Schirmer test, Tear film Break-up time