Acupuncture for Dry Eye Syndrome

Phase 3

Completed

Interventions: Device: Standardized Acupuncture
Device: Non-acupuncture point shallow penetration acupuncture

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standardized Acupuncture group	Standardized Acupuncture	-
Non-acupoint shallow penetration group	Non-acupuncture point shallow penetration acupuncture	-

Primary Outcome Measures

Name	Time	Method
Ocular Surface Disease Index : OSDI	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.

Secondary Outcome Measures

Name	Time	Method
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