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Acupuncture for Dry Eye Syndrome

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Standardized Acupuncture
Non-acupuncture point shallow penetration acupuncture
Sponsored by
Korea Institute of Oriental Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes focused on measuring Acupuncture, Dry eye syndrome, Ocular Surface Disease Index, Schirmer test, Tear film Break-up time

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Center, Korea institute of oriental medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Standardized Acupuncture group

Non-acupoint shallow penetration group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Visual Analogue Scale of Self Symptoms
Schirmer 1 Test
Tear Film Break-up Time : BUT
Medication Quantification Scale (MQS)
General Assessment

Full Information

First Posted
August 31, 2009
Last Updated
December 17, 2010
Sponsor
Korea Institute of Oriental Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00969280
Brief Title
Acupuncture for Dry Eye Syndrome
Official Title
Acupuncture for Dry Eye Syndrome : A Randomized, Patient-Assessor Blinded, Non-acupuncture Point Shallow Penetration-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea Institute of Oriental Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
Acupuncture, Dry eye syndrome, Ocular Surface Disease Index, Schirmer test, Tear film Break-up time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standardized Acupuncture group
Arm Type
Experimental
Arm Title
Non-acupoint shallow penetration group
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Standardized 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.
Intervention Type
Device
Intervention Name(s)
Non-acupuncture point shallow penetration acupuncture
Intervention Description
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 Outcome Measure Information:
Title
Ocular Surface Disease Index : OSDI
Description
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.
Time Frame
Visit 11 (after 3 weeks from baseline)
Secondary Outcome Measure Information:
Title
Visual Analogue Scale of Self Symptoms
Time Frame
every visit
Title
Schirmer 1 Test
Time Frame
visit 1,10
Title
Tear Film Break-up Time : BUT
Time Frame
Visit 1, 10
Title
Medication Quantification Scale (MQS)
Time Frame
every visit
Title
General Assessment
Time Frame
visit 11

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunmi Choi, doctor
Organizational Affiliation
Korea Institute of Oriental Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Taehun Kim, Doctor
Organizational Affiliation
Korea Institute of Oriental Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mi-suk Shin, Master
Organizational Affiliation
Korea Institute of Oriental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center, Korea institute of oriental medicine
City
Daejeon
State/Province
Chongchungdo
ZIP/Postal Code
302-869
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19958541
Citation
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.
Results Reference
derived

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Acupuncture for Dry Eye Syndrome

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