AzTrials
AzTrials

Dry EyePhase 3NCT01105221

Acupuncture for Dry Eye

A Phase 3 study testing Acupuncture and Refresh Plus in people with Dry Eye, run by Korea Institute of Oriental Medicine at 3 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Dry Eye
What is being tested?
Acupuncture and Refresh Plus
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
3 sitesSouth Korea
Study dates
Apr 2010to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
  • Patients whose tear film break-up time is below 10 seconds and Schirmer I test results is below 10mm/5sec.

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Clinical Research Center of Korea Institute of Oriental Medicine

    Daejeon, 301-724

  • Clinical Research Center of DongGuk Univ. Internaltional Hospital

    Goyang-si, Gyeonggi-do, 410-773

  • Clinical Research Center of DongShin Univ. Oriental Hospital

    Gwangju, 503-232

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Dry Eye
Being tested
Acupuncture, Refresh Plus
Keywords
Acupuncture, Dry eye, Artificial tear drop, Mixed method approach, Qualitative study, Cost effectiveness analysis, Tear cytokine analysis
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureDevice

    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.

  • Refresh PlusDrug

    Also called Brand name: ALLERGAN

    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.

Study groups in NCT01105221
Study groupRoleWhat they receive
AcupunctureExperimentalNot described
Receives: Device: Acupuncture
Artificial tear dropActive comparatorNot described
Receives: Drug: Refresh Plus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ocular Surface Disease Index (OSDI)

    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.

    Measured: Up to 13 weeks

Secondary outcomes (9)

  1. Visual analogue scale (VAS) for self-assessment of ocular discomfort

    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.

    Measured: Up to 13 weeks

  2. Schirmer I test with anaesthesia

    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.

    Measured: Up to 13 weeks

  3. Tear Film Break Up Time (BUT)

    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.

    Measured: Up to 13 weeks

  4. General Assessment by acupuncture practitioner and participants

    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.

    Measured: Up to 5 weeks

  5. Self reports about experiences of using other dry eye-related treatments after the end of each intervention.

    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.

    Measured: Up to 13 weeks

  6. Quality of life (QOL)

    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.

    Measured: Up to 13 weeks

  7. Case reports on adverse events for the evaluation of safety

    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.

    Measured: Up to 13 weeks

  8. Qualitative analysis (additional study)

    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.

    Measured: Up to 13 weeks

  9. Cost-effectiveness analysis between acupuncture and artificial tear drop treatment (additional study)

    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.

    Measured: Up to 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionNov 2010
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01105221
Sponsor's protocol ID
KI1001
Status last verified
Apr 2010
First submitted
13 Apr 2010
Last updated
10 Jan 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Choi JB, Hong KE, Lee SD, Choi SM. Acupuncture for the treatment of dry eye: a multicenter randomised controlled trial with active comparison intervention (artificial teardrops). PLoS One. 2012;7(5):e36638. doi: 10.1371/journal.pone.0036638. Epub 2012 May 17.

    PubMed 22615787

  • Kim TH, Kang JW, Kim KH, Kang KW, Shin MS, Jung SY, Kim AR, Jung HJ, Lee SD, Choi JB, Choi SM. Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol. Trials. 2010 Nov 16;11:107. doi: 10.1186/1745-6215-11-107.

    PubMed 21078194

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acupuncture and Refresh Plus in people with Dry Eye, run by Korea Institute of Oriental Medicine at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ocular Surface Disease Index (OSDI) (time frame: Up to 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01105221, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in