Clinical trial NCT01105221: Acupuncture for Dry Eye
Official title: Acupuncture for Dry Eye: a Multicenter Randomized Controlled Trial With Active Comparison Intervention (Artificial Tear Drop) Using a Mixed Method Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye
Keywords: Acupuncture
Dry eye
Artificial tear drop
Mixed method approach
Qualitative study
Cost effectiveness analysis
Tear cytokine analysis
Lead sponsor: Korea Institute of Oriental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: DongGuk University
name: DONGSHIN University Oriental Hospital
First posted: 2010-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Visual analogue scale (VAS) for self-assessment of ocular discomfort
timeFrame: Up to 13 weeks
measure: Schirmer I test with anaesthesia
timeFrame: Up to 13 weeks
measure: Tear Film Break Up Time (BUT)
timeFrame: Up to 13 weeks
measure: General Assessment by acupuncture practitioner and participants
timeFrame: Up to 5 weeks
measure: Self reports about experiences of using other dry eye-related treatments after the end of each intervention.
timeFrame: Up to 13 weeks
measure: Quality of life (QOL)
timeFrame: Up to 13 weeks
measure: Case reports on adverse events for the evaluation of safety
timeFrame: Up to 13 weeks
measure: Qualitative analysis (additional study)
timeFrame: Up to 13 weeks
measure: Cost-effectiveness analysis between acupuncture and artificial tear drop treatment (additional study)
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Clinical Research Center of DongGuk Univ. Internaltional Hospital
state: Gyeonggi
city: Daejeon
country: Korea, Republic of
facility: Clinical Research Center of Korea Institute of Oriental Medicine
city: Gwangju
country: Korea, Republic of
facility: Clinical Research Center of DongShin Univ. Oriental Hospital
Study officials:
affiliation: Korea Institute of Oriental Medicine
name: Sun-Mi Choi, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.