Acupuncture for Dry Eye Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Device: Standardized Acupuncture; Device: Non-acupuncture point shallow penetration acupuncture

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chongchungdo
    • Daejeon, Chongchungdo, Korea, Republic of, 302-869
      • Clinical Research Center, Korea institute of oriental medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Standardized Acupuncture group	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.
PLACEBO_COMPARATOR: Non-acupoint shallow penetration group	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.

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Korea Institute of Oriental Medicine
• Investigators: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): December 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: August 31, 2009
• First Submitted That Met QC Criteria: August 31, 2009
• First Posted (ESTIMATE): September 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2010
• Last Update Submitted That Met QC Criteria: December 17, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Acupuncture; Dry eye syndrome; Schirmer test; Ocular Surface Disease Index; Tear film Break-up time
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: KI0906