Acupuncture for Dry Eye Syndrome

This study has been completed.
Sponsor:
Information provided by:
Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier:
NCT00969280
First received: August 31, 2009
Last updated: December 17, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndromes
Device: Standardized Acupuncture
Device: Non-acupuncture point shallow penetration acupuncture
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study

Resource links provided by NLM:


Further study details as provided by Korea Institute of Oriental Medicine:

Primary Outcome Measures:
  • Ocular Surface Disease Index : OSDI [ Time Frame: Visit 11 (after 3 weeks from baseline) ] [ Designated as safety issue: No ]
    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:
  • Visual Analogue Scale of Self Symptoms [ Time Frame: every visit ] [ Designated as safety issue: No ]
  • Schirmer 1 Test [ Time Frame: visit 1,10 ] [ Designated as safety issue: No ]
  • Tear Film Break-up Time : BUT [ Time Frame: Visit 1, 10 ] [ Designated as safety issue: No ]
  • Medication Quantification Scale (MQS) [ Time Frame: every visit ] [ Designated as safety issue: No ]
  • General Assessment [ Time Frame: visit 11 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: September 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00969280

Locations
Korea, Republic of
Clinical Research Center, Korea institute of oriental medicine
Daejeon, Chongchungdo, Korea, Republic of, 302-869
Sponsors and Collaborators
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
  More Information

No publications provided by Korea Institute of Oriental Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Choi, sun-mi/Principal Investigator, Department of Medical Research, Korea Institute of Oriental Medicine
ClinicalTrials.gov Identifier: NCT00969280     History of Changes
Other Study ID Numbers: KI0906
Study First Received: August 31, 2009
Results First Received: September 17, 2010
Last Updated: December 17, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Institute of Oriental Medicine:
Acupuncture
Dry eye syndrome
Ocular Surface Disease Index
Schirmer test
Tear film Break-up time

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on September 30, 2014