Acupuncture for Dry Eye

January 7, 2011 updated by: Korea Institute of Oriental Medicine

Acupuncture for Dry Eye: a Multicenter Randomized Controlled Trial With Active Comparison Intervention (Artificial Tear Drop) Using a Mixed Method Approach

The purpose of this study is to assess whether acupuncture is more effective than artificial tear drop in the treatment of dry eye.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dry eye is one of the common diseases in ophthalmology. It affects not only patients' daily activities such as reading, carrying out professional work, using the computer, watching television, and driving, but also bodily health conditions such as bodily pain, discomfort and lower energy and vitality.

Currently, artificial tears are easily subscribed or used in the shape of OTC drugs. However, preservatives in artificial tears may exacerbate ocular surface inflammation and the safety of anti-inflammatory treatment is not well established.

Acupuncture, one of the most popular CAM interventions, showed some favourable effects over artificial tears for dry eye in several randomised controlled trials (RCTs). The evidence obtained from these trials is quite limited because all of these RCTs were conducted under high risk of biases. Therefore, well-designed RCTs are needed to establish the efficacy of acupuncture for dry eye.

In a clinical trial, cost-effectiveness and qualitative researches can be carried out parallely. Through this kind of mixed method approaches, various compartments, consisting acupuncture treatment effects are able to be revealed totally.

In this context, the investigators designed a multi-center randomized controlled trial, comparing acupuncture treatment and artificial tear drop with immunoassay for the change of tear cytokine concentration, cost effectiveness study and qualitative research in a mixed method approach.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 301-724
        • Clinical Research Center of Korea Institute of Oriental Medicine
      • Gwangju, Korea, Republic of, 503-232
        • Clinical Research Center of DongShin Univ. Oriental Hospital
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-773
        • Clinical Research Center of DongGuk Univ. Internaltional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 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 (ICD-10 : H04.1). He or she must have both of the conditions below:

    1. Patients who have dry eye symptoms such as itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
    2. Patients whose tear film break-up time is below 10 seconds and Schirmer I test results is below 10mm/5sec.

Exclusion Criteria:

  • Patients who have defects of the eyelid or eyelashes
  • Acute infection of the eyelid, eyeball or eye accessories
  • Stevens-Johnson syndrome
  • Vitamin A deficiency
  • Eye or accessory defects due to external injuries
  • A past history of surgical operation related to the eye in last three months
  • Punctual occlusion
  • Current usage of contact lenses
  • Sequelae of facial palsy,
  • Current usage of anti-inflammatory eye drops in the last two weeks
  • Pregnancy
  • Using history of traditional medicinal treatment such as acupuncture, moxibustion and herbal medicine in the last one month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Acupuncture
Device: Acupuncture
Participants, allocated to this group, will have twelve times of acupuncture treatment in four weeks. Seventeen acupuncture points, which are both BL2, GB14, TE23, Ex1, ST1, GB20, LI4, LI11 and single GV23, will be selected and disposable 0.20*30mm acupuncture needles(Dongbang Co., Korea) will be inserted on these points. Strong 'deqi' sensation will be induced by twisting acupuncture needles and retained for 20 minutes before removed.
ACTIVE_COMPARATOR: Artificial tear drop
Drug: Refresh Plus
Participants, allocated to this group, will be offered preservative-free and single-use Refresh plus (Sodium carboxymethylcellulose). They should use artificial tear in both eyes at least once a day for four weeks.
Other Names:
  • Brand name: ALLERGAN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ocular Surface Disease Index (OSDI)
Time Frame: Up to 13 weeks
This questionnaire is a 12-item instrument for ocular irritation and impact on visual function in dry eye sufferers. It can provide quantifiable results of dry eye symptom frequency and vision-related functioning. Korean version of the OSDI questionnaire will be used. Follow up measurement will be assessed after 4, 5, 9 and 13 weeks from the first visit.
Up to 13 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analogue scale (VAS) for self-assessment of ocular discomfort
Time Frame: Up to 13 weeks
Self-reports on ocular symptoms concomitant with dry eye, such conditions as ocular itching, foreign body sensation, burning, pain and dryness as well as for blurred vision, sensation of photophobia, ocular redness and sensation of tearing. Follow up measurement will be assessed after 4, 5, 9 and 13 weeks from the first visit.
Up to 13 weeks
Schirmer I test with anaesthesia
Time Frame: Up to 13 weeks
This ia a method for checking basic tear secretion. Schirmer test paper (Color Bar™ Eagle Vision, USA) will be inserted on the lateral third of the lower eyelid with the participant's eye closed for five minutes. Follow up measurement will be assessed after 5 weeks and 13 weeks from the first visit.
Up to 13 weeks
Tear Film Break Up Time (BUT)
Time Frame: Up to 13 weeks
This is a method for observing tear film stability. Sodium fluorescein (2.5%) will be instilled in both eyes and the tear break-up time (the interval between the last complete blink and the first appearance of a dry spot or disruption in the tear film) will be measured. Follow up measurement will be assessed after 5 weeks and 13 weeks from the first visit.
Up to 13 weeks
General Assessment by acupuncture practitioner and participants
Time Frame: Up to 5 weeks
Practitioners and participants will evaluate the improvement of ocular symptoms after treatment. They can chose one of the following 5 grades: Excellent, Good, Fair, Poor and Aggravation.
Up to 5 weeks
Self reports about experiences of using other dry eye-related treatments after the end of each intervention.
Time Frame: Up to 13 weeks
For cost-effective analysis, all experience of using other dry eye-related treatments after the end of each intervention should be reported by participants. It contains frequency of hospital visit and treatments methods. Follow up measurement will be assessed after 9, 13 weeks from the first visit.
Up to 13 weeks
Quality of life (QOL)
Time Frame: Up to 13 weeks
One questionaire for QOL, related to dry eye, is asked. Follow up measurement will be assessed after 4, 5, 9 and 13 weeks from the first visit.
Up to 13 weeks
Case reports on adverse events for the evaluation of safety
Time Frame: Up to 13 weeks
Adverse events, adverse acupuncture or artificial tear drop reaction, serious and unexpected adverse acupuncture or artificial tear drop reaction and serious adverse event will be reported by participants and checked by practioners in every visit. Number of participants with adverse events will also be recorded.
Up to 13 weeks
Qualitative analysis (additional study)
Time Frame: Up to 13 weeks
Questionaires with open-ended question about personal experiences for dry eye, acupuncture treatment and usage of artificial tear drop will be distributed to every participant of both group. Follow up measurement will be assessed after 4 and 13 weeks from the first visit.
Up to 13 weeks
Cost-effectiveness analysis between acupuncture and artificial tear drop treatment (additional study)
Time Frame: Up to 13 weeks
Cost-effectiveness of acupucnture will be analyzed using Ocular Surface Disease Index (OSDI) variable, comparing the cost of artificial tear drops. the Cost which all participants will use for dry eye during the trial period, will be recorded in every visit.
Up to 13 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Institute of Oriental Medicine

Collaborators

DongGuk University
DONGSHIN University Oriental Hospital

Investigators

  • Principal Investigator: Sun-Mi Choi, Dr, Korea Institute of Oriental Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 15, 2010

First Posted (ESTIMATE)

April 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2011

Last Update Submitted That Met QC Criteria

January 7, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KI1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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