Acupuncture for Dry Eye Syndrome
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome
Intervention: Standardized Acupuncture; Non-acupuncture point shallow penetration acupuncture
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acupuncture; Dry eye syndrome; Ocular Surface Disease Index; Schirmer test; Tear film Break-up time

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.
    

Eligibility criteria:

        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