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NCT Number: NCT00969280

Acupuncture for Dry Eye Syndrome

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Center, Korea institute of oriental medicine

Daejeon, Chongchungdo, 302-869, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized Acupuncture

Device

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.

Non-acupuncture point shallow penetration acupuncture

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Visual Analogue Scale of Self Symptoms

    Time frame: every visit

  2. Schirmer 1 Test

    Time frame: visit 1,10

  3. Tear Film Break-up Time : BUT

    Time frame: Visit 1, 10

  4. Medication Quantification Scale (MQS)

    Time frame: every visit

  5. General Assessment

    Time frame: visit 11

Sponsors and collaborators

Lead sponsor

Korea Institute of Oriental Medicine

Other Gov

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 1, 2009
Registry last updated
Dec 21, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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